Medicines Promotion - Assessing The Nature, Extent and Impact of Regulation in The Philippines

Pilot of the HAI / MeTA Tool
MEDICINES PROMOTION:
ASSESSING THE NATURE, EXTENT AND IMPACT OF
REGULATION IN THE PHILIPPINES
CONSULTANTS REPORT
Prepared By
Katherine Ann V. Reyes, MD, MPP
Table of Contents
ACRONYMS ...................................................................................................................................................... III
1.0
BACKGROUND ....................................................................................................................................... 1
2.0
OBJECTIVE .............................................................................................................................................. 2
3.0
METHODOLOGY ................................................................................................................................... 2
4.0 RESULTS .................................................................................................................................................. 4

4.1. NATURE AND SCOPE OF REGULATION .................................................................................................................... 4
4.2. REGULATORY BODY: THE FOOD AND DRUG ADMINISTRATION ................................................................... 21
4.3 MONITORING ...................................................................................................................................................... 25
4.4 ENFORCEMENT ................................................................................................................................................... 27
4.5. RELATIONSHIP BETWEEN THE DIFFERENT BODIES / DEPARTMENTS INVOLVED IN MEDICINES
PROMOTION REGULATION ............................................................................................................................................. 30
4.6. DISCLOSURE OF BUDGET FOR PROMOTION AND ADVERTISING..................................................................... 30
4.7 REGULATION OF GENERIC SUBSTITUTION (SUBSTITUTION BY PHARMACISTS) ........................................... 30
4.8 REGULATION OF PRESCRIBING PRACTICES....................................................................................................... 31
4.9 PROVISION OF INDEPENDENT, NON-PROMOTIONAL INFORMATION ON MEDICINES ................................... 32
5.0 DISCUSSION..........................................................................................................................................33
5.1 NATURE OF REGULATION .................................................................................................................................. 35
5.2 IMPORTANCE OF STRONG AND EFFECTIVE GOVERNMENT REGULATION ...................................................... 40
5.3 IMPACT AND EFFECTIVENESS OF REGULATION ............................................................................................. 41
5.4 THE USE OF THE HAI/META TOOL AS A WAY TO INVESTIGATE THE REGULATORY FRAMEWORK........... 42
6.0
CONCLUSION ........................................................................................................................................42
7.0
REFERENCES ........................................................................................................................................43
ANNEX A1. INTERVIEW SCHEDULE: KEY INFORMANT FROM DRUG REGULATORY

AUTHORITIES.................................................................................................................................................46
ANNEX A2. INTERVIEW SCHEDULE: HEALTHCARE PROFESSIONAL INFORMANT .................51
ANNEX A3. INTERVIEW SCHEDULE: PHARMACEUTICAL INDUSTRY, THE INSURERS, AND
THE MEDIA ......................................................................................................................................................55
ANNEX A4. INTERVIEW SCHEDULE: CIVIL SOCIETY ORGANIZATION OR PATIENT GROUP
OR WHO COUNTRY OFFICE........................................................................................................................59
ANNEX B. INVENTORY OF DOCUMENTS REVIEWED WITH PROVISIONS ON REGULATING
MEDICINE PROMOTION ..............................................................................................................................63
ANNEX C. DOCUMENT CHECKLIST ..........................................................................................................66
ANNEX D. DATA COMPILATION TOOL ...................................................................................................74
ii
Acronyms
AdBoard
AO
APEC
ASC
BFAD
CDRR
CME
CPE
DOH
EO
FDA
GMP
HAI
IFPMA
KII
MeTA
MNC
OTC
PCPI
PHAP
PMA
RA
RFO
WHO
Advertising Board
Administrative Order
Asia Pacific Economic Cooperation
Ads Standards Council
Bureau of Food and Drugs
Center for Drug Regulation & Research
Continuing Medical Education
Continuing Pharmacy Education
Department of Health
Executive Order
Food and Drugs Administration
Good manufacturing practice
Health Alliance International
International Federation of Pharmaceutical Manufacturers and Associations
Key Informant Interview
Medicines Transparency Alliance
Multi national company
Over-the-counter
Philippine Chamber of Pharmaceutical Industries
Pharmaceutical & Healthcare Association of the Philippines
Philippine Medical Association
Republic Act
Regional Field Office
World Health Organization
iii
1.0
BACKGROUND
Medicines are important in the management of diseases. Its beneficial use is

optimized when patients consume drugs with appropriate composition, dose, timing,
and with the least possible cost. Since rational use of drugs could be a function of
physicians prescribing behavior and patient compliance, it is important that
physicians, pharmacists and patients receive information about medicines that is
accurate, unbiased, and with clear description of risks and benefits.
However, without a consistent, reliable and accessible source of independent and
non-promotional information on medicines, health care providers and consumers
tend to utilize the much readily available information from the pharmaceutical
industry. The industry though is inherently conflicted between the health goal of
producing medicines and the business goal of achieving profits. This creates a case
for government to regulate information about medicinal drugs that get passed on to
prescribers, dispensers and consumers.
The neo-classical view sees regulation in health care as necessary when the public
needs to be protected from failures of the market1, such as in the case of information
asymmetry between companies that promote their medicines and the prospective
consumers. A broader perspective would posit that the need to regulate is justified
so that equity and protection of health rights is achieved by changing patterns of
medicine consumption towards rational use.2 There is a public health responsibility
to protect health consumers that could lead to irrational drug use especially that
Philippine households direct 40% of their expenditure on medicine. 3 Both
perspectives suggest that regulation aims to serve both economic (e.g., curb
wasteful purchases) and social (e.g., appropriate behavior supportive of rational drug
use) purposes.
Regulatory architecture governing promotion of medicinal drugs may differ between
countries. The World Health Organization (WHO) Ethical Criteria for Medical Drug
Promotion (1998) provides a general guide on the scope of regulation for
governments to consider. According to local institutional capacity, political and
cultural environment, countries could then decide on the scope of regulation, how to
implement it, and how to enforce the terms of regulation. Apart from government,
relevant stakeholders such as the pharmaceutical companies, professional
organization, general media and consumer groups are encouraged to adopt
voluntary system of ensuring compliant medicinal drug promotional and advertising
activities. An effective regulation of medicinal drug promotion is expected to impact
on rational use of medicines. In the recent years, leaders of the Asia Pacific
Economic Cooperation (APEC) agreed to support The Mexico City Principles for
Voluntary Codes of Business Ethics in the Pharmaceutical Sector that aims to
1
Marc Roberts, et al. (2004). Introduction to Health Care Regulations IN: International Comparative Review of
Health Care Regulatory Systems. New York: Oxford University Press, Inc.
2
Kabir Sheikh, Prasanna Saligram, and Lakshmi E. Prassad. 2013. Mapping the regulatory architecture of for
health care delivery in mixed health systems in low-and middle-income countries. Melbourne, Australia: Nossal
Institute for Global Health
3
National Statistics Office (2009). Family Income Expenditure Survey 2009
strengthen ethical practice by pharmaceutical companies with respect to their

interaction with health care professionals. In 2013 the Philippine Food and Drugs
Administration (FDA) adopted this Principle.
Medicines Transparency Alliance (MeTA), a multi-sectoral collaboration working to
improve access to medicines conducted two relevant local initiatives in 2010 that
focused on medicines promotion. A multi-stakeholders workshop on ethical drug
promotion and marketing was held. This was complemented by a commissioned
study, Survey of Promotional Practices in the Philippine Pharmaceutical Industry.
Both provided input to the succeeding efforts on defining the boundaries of drug
promotion in the Philippines. An acceptable scenario would have any form of
promotional activity that will not impact negatively on rational drug use. Having the
industry stakeholders adopt a code of practice consistent with the Mexico City
Principles would be good; achieving a strong, relevant, effective, and efficient
government regulatory framework would be better.
As such, the question that needs to be answered in the area of medicines promotion
in the Philippines is this: What is the appropriate mode and mechanism of regulating
the promotion of medicinal products such that rational drug use is protected?
2.0
OBJECTIVE
The general objective of this study is to develop country-specific policy

recommendations on medicines promotion to ensure adequate and effective
regulation that will promote rational drug use.
To achieve this objective, this study aims to specifically:
1.
Provide a detailed overview of the current regulatory structure for medicines

promotion in the Philippines;
2.
Assess the effectiveness of pharmaceutical promotions regulations and

recommend measures to improve implementation and enforcement;
3.
Identify gaps in the medicines regulatory framework which need to be

addressed; and
4.
Assess the effectiveness of the HAI/MeTA methodology as a tool to

determine the scope of medicines regulation and enforcement mechanisms in
the country setting.
3.0
METHODOLOGY
The scope of Philippines regulatory framework on medicinal drug promotion was

assessed through a thorough literature search. Literature search yield was
systematically catalogued using the Document Checklist, a tool developed by

Health Alliance International (HAI) / Medicine Transparency Alliance (MeTA). 4 A
complementary Data Compilation tool provided a more detailed structure of
mapping out four aspects of the regulatory framework: scope of regulation, the
body/ies responsible for issuing the regulation, the body/ies in-charge of monitoring
regulation and finally, the body/ies tasked to enforce regulation.
This tool complements the structure and principles highlighted in the WHO Ethical
Criteria for Medicinal Drugs Promotion that serves as the international guide for
pharmaceutical promotion.
In the review of literature, examples of existing forms of unethical promotion
occurring in the country were likewise identified. According to evidence gathered, the
manner by which these practices breach legislation or codes of practice will be
described.
A series of semi-structured key informant interviews were conducted over a 4-week
period to confirm findings and fill information gaps that were not collected from
existing documents / literature. Using a tool designed by HAI/MeTA, the interview
schedule was also intended validated the information gathered from literature
(Annexes A1 to A4). Perceptions of key stakeholders on the state of medicinal
drug regulation in the country were elicited. The personalities interviewed were to
cover three broad categories of stakeholders: drug regulatory authorities, healthcare
professionals, and civil society/patient group/WHO country office.
The interview was conducted over a period of four weeks in which a total of 22
respondents were able to fully participate. The rest either decided that they are not
an appropriate key informant, a few could not set a schedule during the study period,
while the rest could not participate in the interview.
Government
Industry SelfRegulatory
Body
Professional
Association
ResearchBased
Four respondents representing different roles and functions in

the regulatory body
All target respondents were interviewed face-to-face
Three respondents from a research-based industry association
with recognized self-regulatory mechanism and two from a local
industry association with beginning steps towards self-regulation
Two target respondents were interviewed face-to-face, two
responded via email
One respondent represented a target respondent who was not
available during the time of interview
Two out of three professional associations invited were able to
participate; One respondent was the actual person invited while
the other one was a representative
One professional association that was invited did not have any
free schedule during the duration of the interviews
One of the two target key informant was able to participate in
the face to face interview while the other did not have time or
MeTA and HAI. Medicines Promotion: Assessing the Nature, Extent and Impact of Regulation. Report and
Preliminary Methodology for Pilot-testing.
Industry
Local Industry
International
distributor
Local retailer /
Distributor
Insurance
Civil Society
Organization
Patient Group
Alliance
Advertising
Group
schedule during the interview phase

One representative form a local industry was able to participate
in a face-to-face interview
The target respondent was interviewed face-to-face
Three out of five key respondents were interviewed face-to-face
One of those who were not able to answer assessed that they
are not the best informant while the other one did not want to
participate
The target respondent was not available during the day of the
interview; representative was able to discuss briefly to say that
their agency does not have much participation when it comes to
regulation of medicine promotion
The plan to send an email response within the study period did
not materialize
Of the five CSOs invited, four were able to do the face-to-face
interview. The fourth one was initially able to schedule but this
did not materialize
The sole target respondent was able to participate in a face-toface interview
The target respondent was able to accommodate a face-to-face
interview
The initial target group was reached by phone and email in
which they decided that they are not the best respondent and
the investigator was referred to colleagues
Succeeding exchanges did not yield substantial and specific
content relevant to medicines promotion
Majority of the interviews were conducted in a face-to-face meeting in a venue most

convenient to the respondent. Each interview lasted between one hour to one hour
and a half. Informants who were interested to participate but for some reason could
not do the face-to-face interview answered the questionnaires and submitted the
completed form via email.
4.0
RESULTS
4.1. Nature and Scope of Regulation

Having clearly written regulatory instruments is important in defining the scope of
regulation. How the scope describes the legal structures serves as the foundation of
drug regulation framework in a given country.
Globally, there are benchmarks designed by assembly of experts, but these are not
legally binding.
WHO Ethical Criteria for Medicinal Drug Promotion (1988)5
The World Health Assembly brought forth a recommended framework

towards ethical medical drug promotion, with the overall aim to uphold rational
medical drug use. The general principles presented by the document can
serve as a guide, with no assumption of legal obligations from member
countries, with the understanding that nations may require different
mechanisms for regulation to work. Further, the ethical criteria are to be
applied for prescription and non-prescription drugs, traditional medicines and
all products that are marketed as medicine. Philippines subscribes to this
guideline.
Mexico City Principles for Voluntary Codes of Business Ethics in the

Biopharmaceutical Sector (2011)6
Six principles were set to guide relationships of pharmaceutical companies

with healthcare professionals and other stakeholders. It is urged that these
interactions remain ethical so that patients benefit from best decisions made.
Very recently, the country adapted this Code as a national guide for the
pharmaceutical industry to follow.7
International Federation of Pharmaceutical Manufacturers & Associations

(IFPMA) Code of Practice (2012)8
The Code of Practice has eight guiding principles that are expounded in the
document. This Code applies to all IFPMA members and is used to ensure
the ethical promotion, selling and distribution of medicinal drug products.
There is particular focus on managing the interactions between the
pharmaceutical companies and different stakeholders.
Facets of regulating the promotion of medicines are found in several
instrumentalities - legislative acts on health, in the national medicines policy, and in
the countrys consumer act. Annex B has the full list. Complementary are two
published voluntary codes that of the Pharmaceutical and Healthcare Association of
the Philippines (PHAP) directed to its 46 member companies plus the local
subsidiaries of IFPMA member companies and the Philippine Medical Association
(PMA), which is designed for member doctors.
WHO (1988). Ethical criteria for medicinal drug promotion
6 APEC (2011). The Mexico City Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical
Sector
7
FDA (2013). Circular No 2013-024 Adoption and Implementation of The Mexico City Principles for Voluntary
Codes of Business Ethics in the Biopharmaceutical Sector.
8
IFPMA (2012). IFPMA Code of Practice
Table 1.a. Mapping of regulatory provisions referring to regulation of medicines promotion in the Philippines
- mentioned; - not mentioned
Scope of Regulation
(HAI/MeTA Tool)
Advertisement is
defined
WHO Ethical Criteria for

Medicinal Drug
Promotion (1988)
The Mexico City

Principles
Philippine Legal
Provision
BFAD Regulation 5
1987 s1.a
Pharmaceutical and
Healthcare Association
of the Philippines
Definition, Appendix
Philippine Medical
Association
Definition, Appendix
Guiding Principle, 2.4,

2.5, 2.7.1, 2.8
DOH AO 65 1989 s1.1
Promotion is defined
Consumer Act of the

Philippines 1991 Art 4.b
BFAD Regulation 5
1987 s1.b
DOH AO 65 1989 s1.2
Provisions on
promotion/advertiseme
nt is specified
Section 2.A, Section

2.B
Consumer Act of the

Philippines 1991 Art
1.bm
BFAD Regulation 5
1987 s2
Generics Act of 1988.
Section 2 & 4
DOH AO 65 1989 s2.2
Consumer Act of the
Title III, Art 48, Art 50,
Title III, Chapter IV, Art
74, Art 86, Art 108, Art
112
DOH DC 2011-0101,
Article V Section 2
FDA Circular 2013-024,
Objectives
Traditional and
complementary
medicines are covered
in a specific way
EO 174 1987 s3
1.1
DOH DC 2011-0101
DOH AO 65 1989 s3.1
2.1
EO 175 1987 s7
2.3.1
EO 175 1987 s5
DOH AO 65 1989 s1
Consumer Act of the
4.ad
Food, Drug and
Cosmetic Act Amended
1992, Section 10
FDA Act 2009 Section
10.f
Compliance with an
approved product
information / label
Specific provisions for
medicines that are
banned from
advertising
DOH AO 65 1989 s2.1

Food, Drug and
Cosmetic Act Amended
1992, Section 11,
Chapter VI, Section 21
Scope of advertising to
the general public
defined according to the
category of medicine
and media channel
FDA Act 2009 Section

11
BFAD Regulation 5
1987 s4 and s5
4.8, 16.1 to 16.10
4.1, 4.2, 4.4
2.3, 3.1, 3.2
Generics Act of 1988,

Section 6.c
DOH AO 51 s1988 14.1
and 14.3
Scope of advertising to
health professionals
defined according to the
category of medicine
and the media channel
Information included in
an advertisement
specified including the
media channel
DOH AO 65 1989 s2.3
DOH AO 51 s1988 15
DOH AO 65 1989 s2.3
Preamble 5

Section 2, 4, and 6.b
DOH AO 65 1989 s3.1,
3.2, 3.3, 3.4
Similar requirements for

advertising between
exported and imported
medicines and locally
produced medicines
Set minimal
qualifications for
pharmaceutical
representatives
MO 133
Section 12.A.1
DOH A0 65 1989 s2.4
8.1 to 8.5
Using the HAI/MeTA Tool, mapping the legislative provisions from the documents
reviewed (Table 1.a) shows that except for a specific guidance on parameters for
promoting domestic and exported medicine products, most of the WHO
recommended general scope of regulation are covered in various legal issuances.
The same can be said by the voluntary code of the PHAP. Although this review was
able to identify corresponding elements between the WHO Guideline and local
legislative instrument, a closer examination would should that the actual content
were not exactly equivalent.
Protecting the Filipinos right to health is enshrined in the Philippine 1987
constitution, and the necessity to instill health consciousness among the people is a
recognized step to achieve this goal.9 Thus, it warrants that interventions that could
help patients decide appropriately for their health must be well supported.
Defining advertisement and promotion
Promotion and advertisement were clearly defined in legal documents. The
Consumer Act of the Philippines10, a piece of legislature providing coverage for
general consumers, spelled out a detailed operational definition of both activities. In
comparison, Guidelines on Advertisement and Promotions to Implement the
Generics Act of 198811 by Department of Health (DOH) and Bureau of Food and
Drugs (BFAD)s Guidelines on Advertisement and Promotions of Prescription
Pharmaceutical Products12 tailored their definition to cover pharmaceutical products
(Note: BFAD is the former name of the FDA).
PHAP Code of Practice also contextualized the definition with reference to
pharmaceutical products.13
Specific provisions concerning medicines promotion / advertisement
According to the WHO guideline, promotion and advertising activities must be within
the countrys legal regulation framework. The information it contains should be
accurate, not misleading and fair.
The Generics Act of 198814 is a landmark decree such that it sets the parameter to
require the use of generic terminology to advertising and promotion. This policy
emphasizes the use of scientifically sound utilization of medicines and highlighting
the role of using generic names in the value chain leading to the dispensing of drugs.
Further, the legislation gives weight to promoting generics that are in the countrys
Essential Drug List. A follow-up issuance by the DOH Guidelines on Advertisement
and Promotions to Implement the Generics Act of 198815 stipulated the necessity of
approval from the then BFAD for claims made in advertising and promotion.
Therapeutic claims must be backed up with very strong evidence and should be
limited only for indications approved by BFAD.
9
Philippine 1987 Constitution, Article II Section 15

Republic Act 7394, Article 4.b and Article 1.bm
11
DOH Administrative Order No 65 s 1989, Section 1.1 and 1.2
12
BFAD Regulation No. 5 s 1987, Section 1.a
13
PHAP, Appendix
14
Republic Act 6675, Sections 2 and 4
15
DOH AO 65 s 1989, Sections 2.1 and 2.2
10
Very recently, DOH through FDA announced that Philippines will be officially and
adapting the Mexico City Principles for Voluntary Codes of Business Ethics in the
Biopharmaceutical Sector. This Code communicates the importance of upholding
professionalism and high ethical standards in the conduct of business between the
pharmaceutical industry and health professionals as well as the regulatory body.16
According to the Code, a countrys regulatory agency must approve a medical
product for marketing before the medicine can be marketed. This approval must also
be consistent with a locally approved product information label. Consistent with the
WHO guidelines, the Code prescribes that any information used in promotion must
be clear, legible, accurate, balanced, fair, objective and sufficiently complete so that
health professionals can make informed decision.17
Complementing the above health laws are provisions in The Consumer Act of the
Philippines 18 that offers a general protection against deceptive, unfair, and
unconscionable sales acts or practices, misleading advertisement and fraudulent
sales and promotion practices. Covered in this act is compelling business to comply
with proper product labeling, which includes food, drugs, cosmetics and devices.
Provisions of the Generics Act will apply in the labeling of drugs. There are
likewise specific requirements for advertising drug products, emphasizing on the role
of approving department as the standard by which violations will be measured
against.
The guideline of PHAP Code of Practice is silent about the use of generics but did
include provision on ethical, accurate and balanced promotion. Their members are
urged to conform to acceptable standards in the country.19
While there are laws already in place generally describing the guidance for
advertising medicines, FDA confirms during the interview that current
advertisements appeal to viewers with claims that may seem believable but are
actually incomplete and exaggerated. Respondents from the professional societies,
industry, civil society organizations (CSOs), and patient group affirm this observation
that advertisements are biased and generally not helpful at all in making rational
choice in medicine use.
Range of regulation: products that are included, products that are banned,
dealing with off-label use, and dealing with domestic- and export-sourced
drugs
Medicinal drug defined - Earlier presidential issuances that contributed to the
National Drug Policy and the Food and Drugs Cosmetics Act anchored its definition
of what are considered as drugs from the US Formulary: (1) articles recognized in
the current official United States Pharmacopoeia or the United States Official
National Formulary (ISP-NF), official Homeopathic Pharmacopoeia of the United
States, official National Drug Formulary, or any supplement to any of them; and (2)
articles intended for use in the prevention of disease in man or animals; (3) articles
16
FDA Circular No 2013-024 Objectives and Rationale

APEC (2013). The Mexico City Principles, Section 2.A and Section 2.B
18
RA 7394, Title III, Article 48, Article 50, Title III Chapter IV, Article 74, Article 86, Article 108, 112
19
PHAP Guiding Principle, Section 2.4, Section 2.5, Section 2.7.1, Section 2.8
17
10
(other than food) intended to affect the structure or function of the body of man or
animals; and articles intended for use as a component of any articles specified in
clauses (1), (2) or (3) but do not include devices or their components, parts or
accessories).20,21 The definition was later on localized to recognize the adoption
and recognition of Philippine Food and Drug Administration. 22 Further, the
terminology is elaborated in Guidelines on Advertisement and Promotions to
Implement the Generics Act 23 as being applicable to pharmaceutical products,
prescription or ethical drugs, and non-prescription drugs/over the counter drugs. This
definition is expanded in The Consumers Act of the Philippines to cover herbal and
or traditional drugs.24
The Consumer Act of the Philippines provided a wider scope of what can be
considered as medicine product and therefore whose promotion must be covered
under the law. Yet, as concurred by all KII respondents, the boundaries appear to be
blurred with regards to traditional products that carry the disclaimer No Approved
Therapeutic Claims.
Prohibitions in advertising and promotion - It is a fundamental requirement for
products to first be registered by BFAD before it could be advertised or
promoted.25,26,27 DOH also prohibits the mass media advertisement or promotion of
products classified by BFAD as prescription or ethical drugs. 28 Misbranded and
adulterated drugs must not also be advertised.29,30
PHAP supports the prohibition of promotion for products that are not registered by
the FDA.31
Off-label use There is no specific legal item that regulates off-label use. PHAP on
the other hand does not recommend the promotion of products on indications that
are not included in their registered indications.32
The common practice is to generally support the non-marketing/non-promotion of
off-label indication even if there is no specific law prohibiting it. KII result concurs
this. Off-label use however is sometimes practiced at the discretion of the
prescriber.
Requirements for exported and imported goods relative to locally produced
medicines No definite guidance on the boundaries of promotion for exported goods
is found among the existing legislative instruments.
None among the KII
respondents were also able to identify otherwise.
20
Executive Order Numbers 174 and 175 Section 3

RA 3720 Section 10
22
RA 9711 Section 10.f
23
DOH AO 65 s1989 Section 1
24
RA 7394 Article 4.ad
25
DOH AO 65 s1989 Section 2.1
26
Executive Order 175 Section 7
27
RA 3720 Chapter VI, j
28
DOH AO 65 s 1989 Section 3.3
29
RA 3720, Section 11
30
RA 9711 Section 11
31
PHAP Section 2.3.1
32
PHAP 2.3.1
21
11
Advertising compliance with approved product information level

WHOs Guideline suggests consistency of advertising and promotional content with
approved data sheet that is scientific and accurate. A prominent directive for
advertising and promotional materials in all media type to prominently feature the
generic name of drug products is spelled out the DOHs Guidelines on
Advertisement and Promotions to Implement the Generics Act of 1988. 33
PHAPs Code of Practice strongly emphasizes the responsibility and accountability
of companies in ensuring that claims must be supported by Product Information,
literature and Data on File.34
Information included in advertising and media type specification
Dissemination of accurate information on drugs and medicines to physicians and
public is encouraged under the National Drug Policy. 35 The Mexico City Principles
urge companies to be responsible for information that are provided to medical
professionals. Information must be objective, accurate, and balanced.36
The legal coverage of inclusion of information on generics is provided by the
Generics Act of 1988.37 The use of generics is required in marketing, advertising
and promotion activities. There is also specific emphasis to promote generics that
are included in the Essential Drug List. The requirement to make generic labels
prominent covers print, visual, or auditory media.38
PHAP Code of Practice provided a wider scope on this clause. 39 It upholds that
information, claims and graphical representations be current, accurate, balanced and
not misleading, with full or abridged product disclosure be made available.
Advertising to the general public
The Generics Act of 1988 strongly urge traditional and non-traditional drug outlets
to inform their buyers about drugs having the same generic name, through verbal
communication and by means of visible posters in their establishments. 40 From the
DOH Central Office, the Public Information and Health Education Service was
tasked to produce and disseminate informational materials so that the public is made
aware about the use of generic drugs.41 All stakeholders, especially the distributor of
pharmaceutical products agree that acceptance of generics has improved since the
formal passage of the law. In a closer look however, much still needs to be done to
change the perception of generics being labeled as cheap when what the
government really intends to convey is accessibility / affordability and quality.
33
DOH AO 65 s 1989 Section 3.1

PHAP Section 2.1
35
Memorandum Order No 133
36
APEC (2013) The Mexico City Principles Preamble 5
37
RA 6675 Section 2, Section 4, Section 6.b)
38
DOH AO 65 1989 s 3.1
39
PHAP 2.3, 3.1, and 3.2
40
RA 6675 Section 6.c)
41
DOH AO 52 s 1988 Implementing Guidelines for Department of Health Compliance with RA 6675 Section
14.1 and 14.3
34
12
Over-the-counter (OTC) drugs can be advertised to the public but there is no clear
legal guideline. Self-regulating PHAP does not also overstep into regulating OTC
advertisement of their member companies. FDA, CSOs and patient group are
particularly concerned how the lack of defined boundaries for OTC advertising could
result to possible misuse by the public. For instance, there are medicines that are
classified OTC in lower doses but will already require a prescription when used in
higher doses. Other vulnerabilities suggested by stakeholders in the KIIs are the
conduct of disease awareness campaigns as well as the creative ways that
marketing strategists are launching products in the market.
Among the drug classifications, prescription and ethical drugs could not be
advertised in any form to the general public.42 PHAP likewise disallows lay media
advertising for prescription products. 43 Any promotion efforts must encourage
health-seeking behavior to appropriate healthcare professional.
Advertising to health professionals
In implementing the Generics Law, a DOH implementing guideline directed the Head
Agencies particularly their respective Therapeutics Committees to conduct
promotional activities on the use of generics, directed to DOH personnel, especially
physicians and nurses.44
Ethical and prescription drugs may be advertised and promoted to medical and allied
professions through marketing collaterals that are directed to this population
segment.45
Advertising to healthcare professionals through medical journals must contain the
prescribed disclosure of information about the drug, as recommended by PHAP. 46
The same should apply for advertisement in MIMS, company commissioned articles,
and even for short advertisements.
Additional note on advertisements generated from foreign sources
Due to technological advancement that enables information to flow from different
sources, advertising and promotional activities that involved medicines can find
channels in non-traditional conduits. KII respondents from the FDA, professional
societies, CSOs, and patient group agreed that this type of information is passed on
through internet, cable television, foreign-sourced magazines and similar platforms.
Typically, it will be the mid- to higher-income group as well as educated individuals
who will have access to such information sources. Unless otherwise proven by
technical investigation, there is a general comment that foreign-sourced information
on medicine, especially those coming from the United States tend to be objective
and compliant with requirements compared to locally produced advertisements.
42
DOH AO 65 Section 3.3

PHAP 4.8 and 16.1-16.10
44
DOH AO 51 series of 1988 Implementing Guidelines for Department of Health Compliance with Republic Act
6675, Section 15
45
DOH AO 65 series 1989, Section 3.3
46
PHAP 4.1
43
13
Requirement for Pharmaceutical Sales Representatives

By adopting the Mexico City Principles, FDA is keen to see that all pharmaceutical
representatives who interact with healthcare professionals be trained about related
regulatory laws. It is the responsibility of the Companies to ensure adequate training
for their representatives.47
Characteristics of good pharmaceutical sales representative were described in the
PHAP Code of Practice. 48 They must have adequate training to represent the
products in accurately through current and balanced information. Representatives
are expected to observe ethical practice by conforming to industry codes and
institutional regulations.
In practice however, the weak guidance on the qualification, skills and conduct of
medical representatives may be the cause of what stakeholders would regard as
unprofessionalism. Pharmaceutical sales representatives are expected to be able to
convey objectively information about the medicines that they sell but this is not often
the case.
Going further in this review, legal articles that pertain to specific promotional
activities were plotted according to the HAI/MeTA Tool, depicted on Table 1.b. In
this table, it is seen that there are very few items covered in legal instruments,
perhaps not enough to provide a thorough guidance for the industry and this was
confirmed during the Key Informant Interview (KII). This could be potentially
strengthened through the effective adoption / localization of the Mexico City
Principles. In comparison, the PHAP Code has guidance for most of the interactions
between the industry and healthcare professional as recommended by WHO.
Promotion and health professionals
o Promotion through gifts/payments to doctors or other health professionals
Regulation according to the Mexico City Principles prohibits the provision of
payments in cash or cash equivalents or gifts that will be for the personal benefit
of the healthcare professional.49
On the other hand, giveaway items directed to individuals for the purpose of
promotion is allowed by PHAP as long as it is of low economic value (e.g., below
P 1,000). More expensive items can never be given to individuals but is
acceptable for donation to institutions.50 The PMA is a little vague in this regard;
it allows gifts of reasonable value that could help patients and are related to the
practice of the profession.51
47
APEC (2013) The Mexico City Principles Section 12.A.1

PHAP 8.1 8.5
49
APEC (2013) The Mexico City Principles Section 7
50
PHAP 4.5.4, 6.1, 6.2-6.5, 13.2
51
PMA Article VI, Section 3
48
14
Table 1.b. Mapping of regulatory provisions referring to regulation of medicines promotion in the Philippines specific stipulations on different forms of
promotion
- mentioned; - not mentioned
Scope of Regulation
(HAI/MeTA Tool)

Medicinal Drug
Promotion (1988)
The Mexico City

Principles
Philippine Legal
Provision
Section 7
Preamble 2, Preamble
3, Section 1.c, Section
5A
FDA Circular 2013-024,

Rationale
Section 9.B
Sponsorship of
Continuing Medical or
Pharmacy Education
Section 8.A.1, Section

8.B
BFAD Regulation 5
1987 s6
Sponsorship of
scientific meetings
Information on patients
(package insert
contents)
Packaging and labeling
Section 4, Section 4.c
Article VI, Section 10,

Article IV, Section 12,
Article IV, Section 16
Article IV, Section 7
EO 175 1987 s7 and

s11
Gifts and payments to

doctors or other health
professionals
Pharmaceutical sales
representatives
interaction with
healthcare
professionals
Discounts and rebates
on medicines
Distribution of free
medicines samples
Pharmaceutical and
of the Philippines
4.5.5, 6.1, 6.2 to 6.5,

13.2
Guiding Principle, 3.0,

4.5, 11.7, 13.3
17.0
9.1 to 9.5
11.1 to 11.2, 11.9 to

12.0
Philippine Medical
Association
Article VI, Section 3
Article VI Section 1

Section 7
15
Consumer Act of the

Philippines 1991 Art 86
Internet and related

social networking media
Post-marketing studies
Clinical trials and

promotion
Promotion of off-label
indications
Others
Section 2.B.4
Section 14.B
Section 6, Section 10.1,

Section 13, Section 15,
Section 16
4.6.1, 5.5, 7.0
14.7
Guiding Principles, 14.0
2.3.1
4.6.1, 5.0, 10.2, 14.8,

15.0 to 15.5

16
Representatives from professional societies, CSOs and patient group did not find
the level of gift giving to healthcare professionals as a cause of concern as it
used to be. There is a perception that some level of giving is permissible
according to Filipino culture of promoting goodwill as long as it abides by
standards set forth by existing rules.
o Promotion through interactions of pharmaceutical sales representatives with
healthcare professionals
The Mexico City Principles promote the observance of ethical relationships
between representatives and healthcare professionals, guided by existing laws
and guidelines. Interactions that will result to undue influence to the prescribing
practice of healthcare professionals are prohibited.52
Consistent with the expected competency of pharmaceutical sales
representatives, their interaction with healthcare professionals is expected to be
ethical at all times, as described in the PHAP Code of Practice.53 Their hospitality
activities directed to healthcare professionals must be within bounds of the Code.
Stakeholders from the professional associations, CSOs and patient groups
agreed that there is a close relationship between health care professionals and
the pharmaceutical industry, mostly due to interactions initiated by the latter.
There remains a general perception that this relationship is driven by the goal to
increase profit for the industry by influence the prescribing behavior of doctors.
o Promotion through sponsorship of Continuing Medical or Pharmacy Education
(CME or CPE) and Scientific Meetings
According to The Mexico City Principles, any financial support to a CME or CPE
must not constitute an inducement to prefer prescribing a particular brand of
medicine or treatment. The same is true with any form of grant, scholarship,
subsidies, consulting contracts, educational or practice-related items. 54 In the
same principle, sponsorship to individual providers for attendance to scientific
meetings should not be conditional to obligation to prescribe, recommend, or
promote any medicine.55
PHAP spelled out restrictions in sponsoring trips to scientific meetings, especially
those which would require travel outside of healthcare providers home country.56
The sponsorship must never be conditional to the obligation to promote or
prescribe any medicinal product.
PMA asserts that continuing medical education must be organized by the society
to benefit patients by ensuring updates to the medical audience.57 Honoraria and
subsidies from the industry are allowed according to the contribution and
52
APEC (2013) The Mexico City Principles. Preamble 2, Preamble 3, Section 1.C
PHAP Guiding Principle, 3.0, 4.5, 11.7, and 13.3
54
APEC (2013) The Mexico City Principles Section 8.A.1 and 8.B
55
APEC (2013) The Mexico City Principles Section 4 and Section 4.c
56
PHAP Section 11 and 12
57
PMA Article IV Section 10, Section 12, Section 14, Section 15, Section 16
53
17
participation in the activity. The use of generics is a priority in the lectures but
companies are allowed to indicate their brands at the end of the presentation.
Similarly, PMA urges full disclosure of sponsorship in the publication or
presentation of articles during scientific conferenced.58
The issue on CME or CPE sponsorships was discussed to all stakeholders
interviewed. There is a general agreement that the industry, except for the
distributor of generic products, does sponsor these conferences for the purpose
of further learning of healthcare professionals. The sponsorship could be a
partnership between professional societies and the industry or it could be a
stand-alone conference with a smaller more targeted audience. The perception
that sponsorship is a vehicle to influence product acceptability still exists.
Professional societies and the industry claim though that sponsorship in societyorganized CME/CPE abides by society policies and will have very minimal
influence from the industry in terms of agenda. Vulnerability for industry-driven
information campaign during educational conferences appear to be higher if the
activity is stand alone and not organized with a bigger society/association that
has well-defined rules on sponsorships.
o Post-marketing studies
Disguising promotion within post-marketing studies activities is prohibited. Postmarketing studies must be strictly for scientific or educational purpose.59
Member companies of PHAP are prohibited from compensating healthcare
providers that participate in post-marketing studies.60 PMA allows its member
physicians to participate in post-marketing studies, with the understanding that
healthcare providers observe informed consent from participants. 61 Physicians
must also report the findings to proper authorities.
o Clinical trials and promotion
The Mexico City Principles prohibits the use of clinical trials for inducement of
sales.62
A detailed guidance on the conduct of clinical studies and related activities is also
provided by PHAP. 63 Transparency and disclosure must be observed in the
conduct of these activities. The purpose of studies and trials must remain for the
furtherance of knowledge and advance of medicine and science. PMA further
clarifies that clinical trials be ethically defensible, socially responsible, and
scientifically valid and must always abide with local provisions on the protection
of human subjects. If there are renumeration, this must not constitute an
enticement.64
58
PMA Section 7
APEC (2013) The Mexico City Principles Section 2.B.4
60
PHAP 14.7
61
PMA Article VI, Section 2
62
APEC (2013) The Mexico City Priciples, Section 14.B
63
PHAP 14.0
64
PMA Article VI Section 5 and 6
59
18
Promotion to health professionals, patients and general public

o Promotions through discounts and rebates on medicines
PHAP prohibits the direct access of patients to discounts or coupons.65 These
promotional items could only be given with the guidance of a physician, with
support of a prescription. Any activity that will cause self-medication is
discouraged.
According to the stakeholders who participated in the KII, there are
undocumented reports that discounts / rebates are extended to doctors allegedly
done by local companies. All of them agree that this should be prohibited. There
is an observation that in some areas in the country, the practice of doctors to
directly dispense medicines may also be fueling this behavior.
There was also an observation that this practice may have already shifted from
involving doctors to pharmacists who are directly responsible for dispensing
medicines. Provision of discounts or coupons directly to customers, particularly
for OTC is still being practiced.
o Promotion through distribution of free medicine samples
Direct giving of samples to the public is prohibited.66 This can be provided with no
charge to healthcare professionals and should be done for the purpose of
improving patient care.67 These samples must not be resold. Upon the consent
of healthcare professionals, pharmaceutical representatives could give free
medicine samples to their person.68 These are not to be sold but to be used such
that initiation of therapy can be done and for the healthcare professional to gain
experience. PHAP further allows the distribution of free medicine samples for
humanitarian reason, but must still be dispensed with physicians prescription.
PMA affirms that physicians must not derive material gain from product
samples.69
Majority of the stakeholders do not see anything wrong with providing doctors
with samples but this must be done properly. There is still no agreement what
constitutes a proper sample but there are common behavior identified to be
desirable: samples must be given to patients for free with proper information and
consent, it must be enough to properly gauge impact, and it must not lead to
wrong / corrupt practices.
65
PHAP 17.0
BFAD Regulation No 5 s 1987
67
APEC (2013). The Mexico City Principles. Section 9.B
68
PHAP 9.1 9.5
69
PMA Article VI Section 1
66
19
o Promotion using the internet and related social networking media

PHAP promotes full disclosure and transparency on the intended audience and
the sponsor company in any pharmaceutical product related websites. 70 Content
must comply with the Code and local regulation. There should not be any
unsolicited electronic transmission or replicas that will be sent to audiences for
promotional purposes.
Packaging, labeling and product inserts
Packaging and labeling should not compromise the safety of consumers.
Misrepresentation, misbranding, and misleading labels are prohibited. 71 This
includes non-inclusion of information required by government to place on labels.
The Generics Act of 1988 calls for drug companies to be accountable in the quality
of drugs being sold by ensuring that generically labeled medicines contain the name
of country manufacture, dates of manufacture, and expiration.72 The Consumer Act
of the Philippines affirmed that provisions of the Generics Act apply in the labeling
of drugs.73
Others
There was a few more guidance provided by The Mexico City Principles.
Sponsorship for sole purpose of entertainment is prohibited.74 Whenever healthcare
professionals are engaged as consultants or speakers to events sponsored by the
Companies, these interactions must not result to inducement for preferential
prescribing. Compensation or reimbursement must be guided by the fair market
value of service rendered.75
Companies may support charitable causes through donations but this must not
constitute any form of promotion. In the process of supporting activities for charities,
donations must not lead healthcare professionals to prescribe improperly.76
In cases when Companies have to deal with the public sector, they must observe
legal boundaries that protect transactions against corruption and undue
inducements.77 A possible vulnerability explored is the case of selecting medicines
for reimbursement in hospitals. Not all stakeholders were familiar of the process.
The few who have some knowledge concur that there is some level of influence from
the industry in the manner by which they detail the physicians, submit product
information to the hospitals therapeutic committee, or participate in the vetting
process. There may be an unintentional bias over the methodology of shortlisting
the participating industry companies, as requirements tend to be favorable towards
the larger research-based firms. More investigation may be required to assess how
70
PHAP 4.6.1, 5.5, 7.0

Executive Order 175 Section 11 Amending Section 11 of RA 3720
72
RA 6675 Section 7
73
RA 7394, Article 86
74
APEC (2013). The Mexico City Principles. Section 6
75
APEC (2013). Section 10.1
76
APEC (2013). The Mexico City Principles. Section 15.
77
APEC (2013). Section 13.
71
20
this transaction impacts on overall use of medicine, particularly in hospital-based

therapeutics.
The industry must respect the autonomy of patients and patient groups such that any
form of support must not be linked with direct promotion of a specific medicine. 78 In
the Philippines, patient group participation or influence in the area of medicine
selection is not pronounced. KII respondents identify two possible groups that do
lobby and these are those that are involved in supporting patients with cancer and
patients suffering from renal failure. There is no perception that these groups are
driven by industry influence, rather they seemed to be motivated by the felt need of
the patients.
4.2.
Regulatory Body: The Food and Drug Administration
In as much as the State provides for the protection of every Filipinos right to health,
the 1987 Constitution likewise covers for the establishment and maintenance of a
regulatory system that will govern food and drugs. 79 Two main national legal
instruments embody the nature and extent of this regulatory body: Republic Act 3720
Food, Drugs and Devices and Cosmetics Act and the most recent Republic Act
9711 Food and Drug Administration Act of 2009. Voluntary / self-regulation by
PHAP member industries and the PMA for its member physicians are governed by
their own Code of Practices.
Philippine Food and Drug Administration (FDA)
The regulatory agency has its beginnings as a subcommittee of Food and Drugs
under the Department of Health in 1961 to 1962.80 At the onset, this subcommittee
was mandated to spearhead the process of drafting a law that will support the
promotion of safe, pure and quality foods, drugs, and cosmetics. Republic Act 3720,
Food, Drug, and Cosmetic Act was enacted in 1963 to provide coverage for such
purpose. It was in 1966 that the Federal Drug and Administration became fully
operational. The FDA was abolished in 1982 to become the Bureau of Food and
Drugs by virtue of the Executive Order 851. BFAD become functional in 1984. Due
to the assessed limitation of BFADs function and scope, Republic Act 9711
reinstated the Food and Drug Authority to replace BFAD. This legal issuance
imputes upon FDA a wider authority and more support to implement improvement in
regulating foods, drugs, cosmetics and hazardous products.
78
APEC (2013). Section 16

Philippine 1987 Constitution, Article XIII, Section 12
80
Food and Drug Administration website http://www.fda.gov.ph/about-food-and-drug-administration/1-history-offda
79
21
Mission and coverage of FDA

The Vision and Mission of the FDA are found on their website and are stated as81:
Vision
Food and Drug Administration to be an internationally recognized center of
regulatory excellence safeguarding the health of the Filipinos.
Mission
To ensure safety, efficacy, purity, and quality of products we regulate through
effective implementation of the national regulatory framework consistent with
international best practices.
As part of its overall function, FDA is expected to prescribe standards, guidelines

and regulations relevant to activities involved in marketing health products. 82
Particularly, the Center for Drug Regulation and Research (CDRR) formulates
guidelines covering applications and approval of promotional, advertisement, and/or
sponsorship materials.83 In particular, the Market Communication Unit under CDRR
is tasked to police drug promotion activities.
FDA is lodged under the Office of the Secretary of DOH.84
Human resource staffing
The Administration is led by a Director General and Deputy Director General.
Specific for drug regulation, there is a Director for the Center for Drug Regulation
and Research. A full time staff manages the Market Communication Unit charged of
the mandate to look after promotion activities involving medicinal drugs.
In general, the informants agree that positions in the FDA are identified by specific
qualification requirements. Individual roles are clear and their performance are
evaluated regularly every six months. Central Office staffs are expected to provide
expertise in defining the regulatory framework. Regional Field Offices are tasked to
monitor activities covered by the FDA mandate but it is admitted that advertising /
promotion activities are not prioritized. A Regulatory Enforcement Unit as well as a
Legal Office oversees enforcement activities.
The main concern is mismatch between the staffing that FDA needs and the actual
allotment that is funded by the government as defined by policies set by the
Department of Budget and Management. This renders some critical positions to be
handled by contractual employees that pose a weakness to an agency whose role is
to regulate practices that impact on health. As it is, one inspector supervises around
500 outlets while only 18 evaluators process more than 2,000 requests annually.
81
Food and Drugs Agency Website, www.fda.gov.ph/about-food-and-drug-administration

RA 9711 Section 4.c
83
FDA Circular 2013-024 Guideline 2
84
RA 3720, Chapter III, Section 4 and RA 9711 Section 4
82
22
Activities related to advertising and promotion is not exactly prioritized when gauged
against other tasks that need to be done in the agency.
Apart from the number of staff, possessing the right kind of skill for the job is another
concern raised during the interview. In the perspective of regulating medicines
promotion, health workers who are the usual human resource complement of FDA
are not particularly trained on how to deal with the industry that it is regulating. It is
not fully determined whether what is required is to hire additional staffs with training
on marketing or is it to spur innovation within the current system so that the
Administration is able to accomplish its objectives within the constraints of its
operation.
Managing possible conflict of interest
There is a specific clause on preventing conflict of interest for the personalities
appointed to the positions of Director General and Deputy Director-General. 85
Previous regular and full-time employment in a regulated establishment will
disqualify a potential candidate in taking up these positions within three (3) years
from termination of employment. Full disclosure of possible conflict of interest is
expected from prospective Director-General and Deputy-Director General.
Respondents to the KII mentioned a standing rule that separated employees must
wait for a period of at least one (1) year before they are allowed legally to take a
position in the industry. However, this is seldom adhered to especially by contractual
staffs who take employment in the industry within this restricted period.
Funding the regulatory activities
The Food and Drug Administration Act mentioned two possible funding sources of
funding. From the budget of the DOH under the General Appropriations Act, there is
an allocation for FDA.86 In addition, FDA is allowed to retain the amount of fees
collected and other similar income. The agency is likewise allowed to accept grants,
donations and other endowments87 but this has yet to be implemented. The Market
Communications Unit has a set annual budget to support its regular program
activities, which so far has been sufficient.
Other activities
Apart from regulating medicinal drugs, FDA is also tasked to look after food,
cosmetics, and hazardous substances. Likewise, on top of regulating advertisement
and promotion activities, FDA has many functions to fulfill. It conducts research,
performs analysis on samples, it sets standards for the industry.88 FDA is also one
of the agencies tasked to implement the National Drug Policy. 89
Public dissemination of information about regulation
85
RA 9711 Section 7.g

RA 9711 Section 21
87
RA 9711 Section 11
88
RA 9711 Section 4, RA 3720, Section 4
89
DOH AO 48 s 1988
86
23
On the website of FDA, can be found decisions, pronouncement, and statements on

regulatory matters. FDA likewise issues paper-based advisories. Occasionally,
broadsheets are used for wider dissemination.
Accountability of FDA
FDA directly reports to the Office of the Secretary.90 Alongside this mechanism is
the involvement of the National Drug Committee that conducts technical reviews on
the decisions and regulations of the then BFAD, now the FDA.91 Another layer of
oversight is provided through the Congressional Oversight Committee who will
review the performance of FDA for five years (or until 2013) after the enactment of
RA 9711.92
Role of the pharmaceutical industry in regulation
FDA recognizes the role of pharmaceutical industry in regulating its own ranks and
that they should be able to do this effectively. PHAP is already widely known to
practice self-regulation especially with their circulated Code, systematic training for
compliance, and established mechanism to processed complaints. PCPI is
perceived as hesitant as it has yet to publish its own Code. During the interview,
PCPI mentioned that there are still provisions in their draft Code that are under
discussion.
With a mechanism of self-regulation in place for a portion of industry members, FDA
however does not require them to report their activities and it also does not exercise
an active oversight function. PHAP expressed that although there is no formal
mandate for them to report to FDA, their system is fully transparent for further
scrutiny, including the performance and outcome of decision making exercised by
their Ethics Committee, the body that processes complaints and potential
vulnerabilities among their member companies.
Alongside the self-regulatory measures implemented (and to be implemented) by the
industry groups, there are inherent rules within each company that binds them to a
certain range of allowable advertising and promotion activities. Multi-national
companies (MNCs) specifically the research-based companies must abide by the
standards set by their home companies that often operate in a more stringent market
system. They regard themselves as having to operate in a stricter environment
because of this set-up.
Local companies on the other hand cite the Good Manufacturing Practice (GMP)
audits conducted by FDA as a mechanism to ensure compliance to prescribed
government policies. GMP audit is done for local companies but not for local
subsidiaries of MNCs.
90
RA 9711 Section 5
DOH AO 48 s1988
92
RA 9711 Section 23
91
24
Role of CSO in regulating medicine promotion and advertisement

CSO representatives who participated in the KII admitted that although medicine
promotion and advertisement is a concern, the issue has not been on top of their
advocacy agenda. There is currently no active participation from the CSOs in terms
of regulating this activity.
At present, the main issue that CSOs actively participate in is providing better
access to medicines. There is interest to widen the scope of their participation as
probably reflected in the plans to organize a Medicines Watch in support of
government. However, the scant funding resource to conduct activities for medicines
promotion regulation is an identified restriction by some CSOs.
4.3
Monitoring
Governments monitoring system

FDA is tasked to monitor advertisement and promotion of drug products. 93 The
agency also receives and processes complaints that could arise from such activities.
The CDRR specifically is tasked to implement compliance measures, monitor
advertisements, promotion and marketing activities. 94 The Regional Field Operation
(RFO) Unit will assist CDRR.
Monitoring body, organizational mission and governance
In the former BFAD, the Legal Division was in-charged of all legal and compliance
aspects that included monitoring of advertisements and promotions. 95 Now, under
the revitalized FDA, this function was transferred to the Center for Drug Regulation
and Research.96 Field inspectors are in the best position to monitor advertisements
but due to the volume of work that they need to accomplish, this is rarely done.
Other activities
FDAs Center for Drug Regulation and Research not only monitors advertising but
also regulates the manufacture, importation, exportation, distribution, sale and
transfer of health products.97
Pre-approval criteria: determination, responsible agency, and application fees
FDAs predecessor, BFAD does not require clearance to the initial printing and
broadcast or dissemination of advertisement and other promotional materials for
medicinal drugs.98 Currently, it was confirmed during the KII that there is no preapproval or screening process on the content of advertisement or promotions
collateral. FDAs focus is mainly on the labels and not on the actual promotional
materials.
Concurrently, there is an expectation that Medical Directors of
93
DOH AO No 65 s1989 Section 4.4

FDA Circular No 2013-024 Guideline 3
95
RA 3720 Section 5f
96
RA 9711 Section 5.a.1
97
RA 9711 Section 5.a.1
98
DOH AO No 65 s.1989 Section 4.3
94
25
pharmaceutical industries should be reviewing and ensuring proper content of

promotional materials but its not being done at the level that it should be.
Once the advertisement goes on air, the Ads Standards Council (ASC) performs
general screening but this is regarded as superficial as technical expertise to
conduct an in-depth assessment may not be present in the ASC. In instances when
a complaint is raised on a particular advertisement material for medicinal drugs, FDA
takes over and processes the issue. FDA likewise must conduct a post-audit on
advertisement materials.
For sales promotion on the other hand, FDA requires the interested party to secure a
permit from the agency to conduct such activity. However, there is no assurance that
this process will examine the entire content and possible effect of promotion to
consumer use of medicines.
Complaint mechanism, publication and timeline
FDA is mandated to receive, process, and decide on complaints about
advertisement and promotion of drug products.99 On the website of FDA, there is a
electronic reporting system (eReport), formally called the FDA Public Assistance,
Information and Complaints Desk. Complaints can be emailed through this portal
and will be directed to the address [email protected]. 100 However, this portal
mainly entertains complaints about customer experience on the products and not on
the advertisement and promotion. The latter has been largely dealt with through
email correspondents. Very recently, FDA issued an internal guidance on how to
handle all complaints including promotions and advertisements but it still has to be
implemented.
Publication of monitoring outcomes
Monitoring of advertisement and promotions ideally is done actively and passively
but in the case of FDA, it is mostly the latter due to resource constraints. There is no
published database on violations.
Monitoring among PHAP members
DOH Guidelines on Advertisement and Promotions to Implement the Generics Act
of 1988 espoused that compliance with guidelines on drug advertisement and
promotion is a responsibility of drug establishment that owns the registration.101 It is
highly suggested that internal review mechanism be present in these companies so
that they are able to comply. In a similar vein, medical companies are encouraged
to actively participate in the industry-wide self-regulation.
This is reinforced by The Mexico City Principles. Companies are to be responsible
to set-up internal mechanism that will support compliance among its staff. It urges
99
DOH AO No 65 s1989 Section 4.4

www.fda.gov.ph/report
101
DOH AO No 65 s1989 Section 4.1 and 4.2
100
26
the leadership to document the internal compliance procedure and have employees
become familiar with it.102
Companies who are members of the Pharmaceutical and Healthcare Association of
the Philippines and local subsidiaries of IFPMA members are covered by the
provision written on the PHAPs Code of Practice. 103 Consistent with the DOH
guidance stipulated in the previous paragraph, the Code imputes the responsibility of
implementing the statutes of self-regulation to the General Managers, Presidents or
Managing Directors of their respective companies.
Monitoring body, organizational mission and governance
PHAPs Code has jurisdiction over its member companies and also over those
whose mother companies adhere to the International Federation of Pharmaceutical
Manufacturers & Associations (IFPMA) Code of Practice. PHAP organizes an Ethics
Committee that reviews cases filed against a certain company.
Complaint mechanism, publication and timeline
Members of the public and the industry can file complaints for any violation done by
a PHAP member company. Complaints arising from the member companies are
encouraged to be settled among themselves rather than elevating it right away to the
PHAP Ethics Committee. 104 A maximum of 95 days is allotted for the cycle to
validate, process, decide, appeal and give the final decision on a complaint received
by PHAP.105
Publication of monitoring outcomes
The PHAP Code of Practice stipulates that a summary of the cases that are being
processed or had been processed shall be published on the PHAP website.106
4.4
Enforcement
Apart from setting the terms and framework of medicines promotion regulation, and
monitoring how it is being implemented, FDA likewise enforces the terms of
regulation. With proven violations, CDRR implements the penalties and violation, in
consultation with the FDA Director General.107
Sanctions and Appeal Mechanism
Violative advertising and promotional materials relative to provisions written about
the role of generics in advertising will result to a cease and desist order from FDA,
102
APEC (2013). The Mexico City Principles. Section 11.

PHAP Guiding Principles, Section 1.3, and Section 18.1
104
PHAP Section 19.2
105
PHAP Section 19
106
PHAP Section 19.10
107
FDA Circular No 2013-024 Guideline 5
103
27
upon formal notification of the responsible company. 108 With the cease and desist
order, the material could no longer be released, printed, broadcasted, or
disseminated. The drug establishment involved could contest FDAs decision and
matters will be settled through a formal hearing. 109 However, repeated violations of
the same serious nature will lead to heavier sanctions that could lead to eventual
revocation of license to operate of the drug establishment.110
When in it is found that advertising and promotional materials involve misbranding of
the drug products, more serious sanction is meted out, including imprisonment and a
hefty fine.111
Even the self-regulating body of advertisers, the Adboard, violative contents will be a
breach of their ethical standards and this will cause print and broadcast materials not
to be advertised.
Range of Sanctions
Violation
Sanction
Violation related to the FDA Act (selling, Corrective
actions
against
promoting, advertising products that are repeated/serious violations
misbranded)
Seizure and confiscation of products
that are subject of violative case of
repeated and serious violations
Withdrawal of the FDA of accreditation
of the drug establishments medical
director
Suspension of the license to operate of
the drug establishment
Cancellation of the CPR
Revocation of the license to operate of
Penalties
for
advertisement
of
misbranded products
Imprisonment ranging from one (1)
year to not more than ten (10) years
OR
Fine of not less than fifty thousand
pesos (P50,000) but not more than five
hundred thousand pesos (P500,000)
OR
Both
Administrative sanctions
(RA 9711 Section 11)
Violation of guidelines about the role of Cease and desist order on the
108
DOH AO No 65 s 1989 Section 4.5

110
111
RA 9711 Section 11
109
28
generics in advertising
Repeated serious violation on the
guidelines about inclusion of generics in
advertising
Violations in general advertising ethics

as governed by Adboard
Violations on advertising practices
according to the Consumer Act
Violation
on
promotion
practices
according to the Consumer Act
advertising activity
(DOH AO No 65 s1989 Section 4.5)
Withdrawal of accreditation, suspension
of license to operate, cancellation of the
certification of the product registration,
and revocation of license to operate of
(DOH AO No 65 s1989 Section 4.7)
All media will refuse to print or broadcast
violative advertising materials
Fine of not less than Five hundred
(P500.00) pesos but not more than
Five thousand (P5,000.00) Pesos; or
Imprisonment of not less than one (1)
month but not more than six (6)
months or both upon the discretion of
the court
Issuance of cease and desist order
(RA 7394 Art 110-115; Art 123)
Fine of less than Two Hundred
(P200.00) Pesos but not more than Six
Hundred (P600.00) Pesos; or
Imprisonment of not less than one (1)
month but not more than six (6)
months or both upon the discretion of
the court
(RA 7394 Art 116-121)
On top of these legal sanctions, PHAP also imposes penalties to members that
violate any provision of the Code. First offense would cost the offender two hundred
thousand pesos (P200,000) and any repeat of the same violation will impute
additional seven hundred fifty thousand pesos (P750,000) per offense. 112 However,
in the occasion that a violator does not commit any more offense of the same nature
within a 12-month period, a clean slate status can be declared to the former
offender.
For doctors who are under the jurisdiction of PMA, there is an ethics committee that
provides a mechanism to process and enforce possible violations in the Code. A
substantial evidence proving that a violation was committed could result to
reprimand or suspension. Results of such decision is not published.
Reporting
DOH, through the Office of the Secretary could report and illustrate the results of
investigations relevant to the products it regulates 113 but this is not yet routinely
done.
112
113
PHAP Section 19.9

Executive Order 175 Section 21, amending RA 3720 Section 29
29
4.5. Relationship between the different bodies / departments involved in

medicines promotion regulation
The FDA is an agency under the Office of the Secretary of DOH. DOH on the other
hand is a member of the National Consumers Affairs Council, whose task is to
improve the management, coordination and effective of programs that affect
consumers.114 However, this is a rarely used mechanism by the FDA in terms of
augmenting its capacity to regulate medicines promotion. What is occasionally
tapped into is their partnership with the ASC and their standing agreement for the
latter to do screening of advertisements.
4.6.
Disclosure of budget for promotion and advertising
All businesses registered in the Philippines are required by the Bureau of Internal
Revenue to disclose their annual Financial Statements, which when done correctly
should include spending related to advertising and promotion. 115 All respondents of
the KII from the pharmaceutical industry who were asked about this information said
that budget for promotion and advertising is private and confidential. Three
respondents discussed this matter further and posited that the cost of advertising
and promotion may no longer be a significant driver of medicine cost. There has to
be an acceptable level of cost devoted to promotion and advertising as long as it is
able to achieve patient-centered objectives of sharing the proper information on
drugs. It was suggested that it may be time for government to conduct an objective
assessment whether promotion and advertisement cost remains a significant
contributor to medicine price or other schemes (e.g., transfer pricing) are causing
this phenomenon.
4.7
Regulation of generic substitution (substitution by pharmacists)
A DOH issuance supporting the Generics Act defined generic dispensing as

dispensing the patients/buyers choice from among generic equivalent. 116 With the
informed choice of the patient/buyer, all drug outlets are required to practice generic
dispensing, with some exemptions, modifications or qualifications.117
Generic dispensing is practiced at the pharmacy level and FDA said that it is allowed
and acceptable as long as the substitution is within the formulary and the medicines
are therapeutically equivalent. Patients must likewise be properly informed and their
consent secured when a substitution is done. Pharmacists and their assistants must
be ready to do the substitution properly where patients are guided using a
substitution card.
114
RA 7394, Title V, Article 148 and 149

Republic Act 8424
116
DOH AO 62 s1989 1.4
117
DOH AO 63 s1989 3.1, 3.1.1
115
30
KII respondents who represent the medicine distributors said that this practice is
acceptable to consumers especially those who are seeking out more affordable
alternatives.
4.8
Regulation of prescribing practices
First off, only licensed and registered medical, dental, and veterinary practitioners
are allowed to prescribe drugs.118 Prescription by the medical, dental and veterinary
professionals shall include the generic name, even as the brand name may be
included.119 Further prescriptions must contain the minimum required information
such as the name of prescriber, office address, professional registration number,
professional tax receipt number, date of prescription and patient/clients name, age
and sex. 120
DOH requires all its facilities to exclusively use generic
names/terminology in doctors prescriptions and orders.121
In general, stakeholders agree that with respect to prescribing in generics, doctors
remain to prescribe their preferred brands at one time or the other. This is observed
in both public and private practice. Compared to doctors in practice however, there
is recognition that those who are serving in public health facilities tend to prescribe in
generic and has been increasingly compliant with the Generics Law.
Stakeholder respondents representing drug distributors cited examples of violations
that some healthcare providers employ despite of the Law. There are doctors who
would write Do Not Replace on the prescription pad. There are those who do write
both generic and brand name but the generic label is not readable.
No active monitoring to keep the prescribing practice of physicians in check.
Patients are deemed to affect the prescribing practice of physicians. This is usually
observed among those who are the capacity and willingness to pay for the brand of
their choice. This behavior is probably influenced also by the high out of pocket
expense for medicines that shifts the purchasing power to individuals. The same
group of consumers has access to information that makes them more likely to
request for alternatives form what doctors prescribe. On the same note, knowledge
and access to generic alternatives has also led to increasing trend in requests for the
more alternative.
Note on the availability of prescription medicine over the counter
Irregularities in prescribing practices are worsened by the availability of prescription
medicines over the counter. The extent of this wrong activity is not known but there
is general agreement that this is widespread. Due to lack of monitoring and
enforcement of appropriate penalties, patients can readily purchase ethical drugs
without proper prescription. Local distributors mentioned that they are putting in
measures to moderate this practice. One intervention is allowing the purchase
118
DOH AO 62 s1989 2.1

RA 6675 Section 6.a
120
DOH AO 62 s1989 2.2
121
DOH AO 169 s. 2004
119
31
without prescription only for those who are already in their database and are buying
for the same indication for a chronic condition.
Aside from the non-compliance from the pharmacies who dispense without
prescription, patient income situation can be a factor why they choose to purchase
even without doctors advise. Given a limited money, patients would rather seek
advise from pharmacy staffs and spend what they have directly for medicines rather
than divert some of that fund towards professional fee payment.
Note on black market peddling of medicines
Almost all stakeholder respondents assent that there is some form of black market
of medicines especially for antibiotics. This is happening even with the fact that
ethical drugs can be purchased from legitimate point of sale without proper
prescription. This can be an indication of unmet need for medicine access and the
concurrent weak monitoring and regulation by government. Black markets are
identified in sari-sari stores (small convenience stores), itinerant vehicles,
supermarkets, and even online market place.
4.9
Provision of independent, non-promotional information on medicines
There are some avenues for DOH to independently provide the public information
about medicines, in particular about encouraging the use of generics. The Generics
Act for instance mandates DOH to publish in a national broadsheet a list of drugs
and medicines in the Philippines, with their generic and brand name. This should be
done at least once a year.122 Complementary to this activity that targets the general
public, is a recommended joint activity between DOH, Department of Education,
Philippine Information Agency and the Department of Interior and Local Government
that will facilitate the continuing education of the public and the health professionals
on the benefits of using generics.123,124
In instances when the DOH deemed it necessary to inform the public about a
potential danger to health or an abject deception to consumer, the Office of the
Secretary could disseminate to the public these important information.125
However, the lack of access to independent information on medicines from the
government still renders the pharmaceutical industry as the main source of
information. Publicly available literature such as MIMS or PPD is not user friendly
for lay users.
Source of information for health care practitioners
Most practitioners are trained to seek out information from academic sources (e.g.,
internet, books, journals, meetings, and scientific convention). These sources are
122
RA 6675 Section 5
RA 6675 Section 11
124
DOH AO 51 s1988 5.3
125
Executive Order 175 Section 21 Amending RA 3720 Section 29
123
32
considered as independent from pharmaceutical industry. Treatment guidelines are

also useful resource but not all health care practitioners are using these properly.
Source of independent information to patients
As of now, doctors would be the best resource who could provide patients objective
information about medicine but the limited encounter time also shortens the content
of info passed on to patients. Patients who are more educated and are better
economically can also source information from relatively independent sources.
FDA can consider these sources of information mentioned above when designing
how to provide info that will support rational drug use.
5.0
DISCUSSION
There were three standing assumptions from previous studies on the impact of
medicines promotion that deemed important enough to justify attention to regulatory
practices126,127:
Medicine information from pharmaceutical companies tend to be biased

towards over promotion of benefits and undermining risks;
Healthcare professionals and the public rely more and more to industrygenerated information to update their knowledge about medicines; and
This information exerts a significant influence in the prescribing, dispensing
and consumption of medicine; there is a general tendency towards irrational
drug use as a result.
Inherent to the business model of pharmaceutical companies are activities that

advertise and promote medicinal drug products to increase sales and recoup the
investment made in drug development. However, medicine intake is not without
risks. Unnecessary antibiotic use for example can lead to resistance that will result to
an even larger public health problem. In this interplay among the pharmaceutical
industry, health workers and general public, it is important that correct information is
filtered through the right media to prevent needless purchase and encourage rational
use. The impact of irrational drug use stemming from improper and unethical
promotion of medicines justifies government resource to regulate this practice.
Pharmaceutical industry promotion tactics can directly and indirectly influence health
worker prescribing behavior. Ideally, educational and professional institutions had
properly guided physicians on how to properly deal with these inducements.
However, this is not always the case; prescribing pattern could be another source of
irrational drug use.
Similarly, medicine users could also be exposed to
advertisements that may sway their purchasing.
126
127
WHO/HAI, 2005
Wazana, 2000
33
It is in this environment that government must shape a regulatory system that could
effectively contain behaviors towards collective good (Figure 1). By identifying
proper aspects of these interactions that could be acceptably controlled by
regulation, then have the capacity to implement these measures, and have the
political and institutional capability to enforce the rules, government is then able to
ensure rational drug use.
Regulation in the health sector has to be designed such that government could
effectively use its legal mandate through policy instrumentalities with the goal to
improve health system performance.128 In the case of regulating the promotions of
drug products, the objective is to eventually support rational drug prescription and
use.
Regulatory System that is Politically, Culturally, and Institutionally Feasible
Pharmaceutical
Manufacturer and
Distributor of
prescription, nonprescription
medicines,
traditional
medicines, and
products promoted
as medicines
Physicians (Prescribers)
Pharmacist, Dispensers
Health Workers involved in the
supply and distribution of
medicines
Universities
Teaching
Institutions
Professional
Associations
Promotion Industry
Professional and
General Media
Patients, Buyers, General Public
Curb Wasteful Use of Medicine

Support Rational Drug Use
Figure 1. Environment of medicinal drug promotion and rationale for regulation
There are five key steps to regulating behaviors of stakeholders that are being
128
World Bank. Health Systems Regulation,

http://web.worldbank.org/WBSITE/EXTERNAL/TOPICS/EXTHEALTHNUTRITIONANDPOPULATION/EXTHSD/0
,,contentMDK:22523877~menuPK:6485077~pagePK:148956~piPK:216618~theSitePK:376793~isCURL:Y,00.ht
ml
34
regulated. 129 Often, a national regulatory framework is determined and expressed as

a law or policy issuance. From the legislative level, the law can be further
operationalized and interpreted through simplified codes and industry standards.
Once the parameters are described and disseminated to the concerned
stakeholders, government and relevant bodies who are given the proper authority
will proceed with monitoring activities to ensure that the regulated industry comply
with the standards. In the process of monitoring, identified violations will be subject
to enforcement with sanctions that will deter violation of rule. Finally, the
effectiveness of the regulatory framework and implementation is evaluated so that
weakness can be identified and subsequently strengthened. Implementing a
national regulation is also resource intensive and every investment on it must
translate into better behaviors from the regulated parties.
5.1
Nature of Regulation
For any type of regulation, framing or writing the rules is very critical. Specific and
clear rules facilitate effective implementation. National laws with provisions on
regulating industry behavior on promotion and advertisement provide general terms
of acceptable and non-acceptable parameters.
In the issue of medicines promotion, what surfaced from this review is the need for
the regulatory framework to describe the rules on how information is channeled such
that:
-
the bias of industry-generated information is reduced;

access to objective and non-promotional information on medicines is made
available to healthcare professionals and the public; and
the transfer of information form industry to health care provider will not induce
irrational behavior.
Using the HAI/MeTA Tool and WHO Guidelines as benchmarks, there exists laws
that clarified legal provisions on the definition, scope, and nature of drugs that can
be promoted to specific audience the public or the health care professionals. There
are provisions that provide parameters on compliance with approved product
information, ensuring the accuracy of information, and instructions on labeling and
packaging of product inserts. Defining the scope of what are medicinal products
that it should also include traditional and herbal products is clear but there is no
defined guidance on how to regard them with respect to promotion restrictions as
they seem to enjoy a wider berth than registered over-the-counter (OTC) drugs with
the disclaimer being There is no approved therapeutic claims.
The legislative documents were likewise silent about boundaries for export products
or even guidance for information coming from international jurisdiction.
The backbone of Philippine legal mandate rests on the strong emphasis in the
preference for use of generics drugs. This study did not include a review on the
performance of the generics law per se thus issues on implementation will not be
129
WHO/HAI Regulation of pharmaceutical promotion: why does regulation matter? IN: Understanding and
Responding the Pharmaceutical Promotion
35
discussed here. That notwithstanding, in relation to medicines promotion, the

generics law appears to be focused more on labels rather than the actual information
content.
For self-regulation, PHAP is silent about generics but it does have very good
guidance on the overall emphasis on abiding by what is acceptable in the law
pertaining to medicines promotion. On the other hand, the code of the Philippine
Medical Association (PMA) did not mention much about general parameters of
regulation but instead focused on guidance for direct interaction of doctors with the
industry.
While general stipulations on medical advertisement and promotions are mentioned
in national laws, there are items that were not covered especially those that refer to
the direct interaction of the industry with health professionals. This can be responded
to by the decision of the government to adopt the Mexico City Principles that
complements the existing laws well.
There are also no national-level legal instrument to guide the proper qualification of
pharmaceutical company sales representatives and how they should conduct
themselves with health care professionals. There are likewise no explicit terms
governing
gifts/payments
to
doctors,
sponsorship
during
continuing
medical/pharmacy education, conduct of post-marketing studies, clinical trials, use of
discounts/coupons, and free medicine samples. No mention on off-label use,
advertising terms for imported or exported goods and the use of internet and social
networking can be found in national legislations. With the adoption of the Mexico
City Principles, government must then need to move this further and consider how to
translate this into operational format to properly address the gaps stated.
As such, current legal issuances may not need a major overhaul as most of the
required general parameters are in place. What is needed are clearly stated
guidance and processes to strengthen the impact of existing laws by effectively
communicating what government wants done. Priorities identified in this review are
clarifications in the following areas:
Patients good outcome as the goal, the pathway for this to be achieved by
regulation, and the manner by which progress / success is measured
Regulating the information passed along during promotional and advertising
activities must be properly and objectively contextualized within the overall
goal of improving patient outcome.
Generics as a logical option for access and quality, not just because its
cheaper
Better description of boundaries for advertising and promotion:

o Scope of what is considered as medicine vs products marketed loosely
as food supplements
o Governments reach over exported medicines
36
Proactive stance from the government in reducing information bias from

promotional and advertising materials and activities
o Screening content
Active mechanism from the government to provide appropriate and nonpromotional information on medicines and rational drug use, not being limited
by simply promoting generic drug use
o Identification of appropriate channels and using it for efficient information
control (internet)
Effective structure to manage a professional transfer and exchange of

information from and between the industry and health care professionals
o Maximizing the strength of self-regulation as a way to improve compliance
with the Mexico City Principles but without taking out the reach and
influence of government regulation / oversight
o Upholding the accountability of companies over the conduct of its medical
representative
o Capitalize on the structures and process of professional societies in
influencing the ethical attitudes and behaviors of health care professionals
especially in dealing with gifts, incentives, and medicine samples, and
protecting the integrity of scientific information dissemination during
CME/CPE
Professional societies could consciously and deliberately influence
health care even at the onset of their training. Providers must be made
aware of potential vulnerabilities and be provided with skills on how to
avoid these.
o Harnessing the role of hospital therapeutic committees in minimizing the
influence of the industry in selecting medicines in the hospital formulary
o Empowering civil societies and patient groups as partners
The above guidance has to be equally applied to all participants who are selling
products marketed as having medicinal effects. FDA will need to discuss and
negotiate with stakeholders how the parameters that it will set will result to an even
playing field for the industry. In crafting the guideline, FDA will likewise need to
improve on describing clearer procedures for regulation as well as articulating the
substance of regulation. Regulated bodies need to be clear on the procedures but
they also need to understand and buy into the rationale for each.
In a survey commissioned by MeTA in 2010, 130
Performance of the Regulatory Body in Implementation and Enforcement

FDA is the sole government regulator with jurisdiction over medicines promotion. It
is legally established through a Republic Act, consistent with the constitutional
mandate to establish an agency that will ensure the health and safety of the general
130
MeTA (2010). Survey of Promotional Practices in the Philippine Pharmaceutical Industry. Compendium
Edition.
37
public. Its vision and mission spells out that it is responsible for a wider scope of
regulation involving food, drugs, and hazardous products.
In the 2010 assessment of Philippine health regulatory system, it was assessed that
FDA failed to regulate unethical marketing practices of pharmaceutical
companies.131 The inability to curb excessive marketing and promotion led to brand
loyalty that not only gave pharmaceutical companies power to set prices above
competitive ceilings, it eventually resulted to irrational drug use. Organized drug
industry association (i.e. Philippine Healthcare Association of the Philippines)
responded by installing self-regulatory activities but this remains limited relative to
the larger ecosystem of unaffiliated and local drug companies.
Three years after, the general assessment remain unchanged. As the body that
defines the regulatory framework and at the same time conducts the actual
implementation, monitoring and enforcement, FDA has a tall mandate to fulfill. In this
brief review and discussion with stakeholders, the following priorities were suggested
for consideration:
Organizational alignment such that bureaucratic form conforms to the function

expected for FDA
There are skill sets needed so that FDA staffs assigned to the spectrum of
tasks in regulating the information flow of medicines promotion and
advertising. Technical guideline development for instance will need actual
field experience and proper legal background such that procedures are
crafted well. Active monitoring or pre-approval process will also require skills
in uncovering nuances in the content of promotional/advertising materials.
FDA has for instance recently required pre-approval of sales promotion
activities132, which is an improvement from an earlier DOH issuances. This
could facilitate better tracking of promotion activities when these activities are
registered with FDA. If FDA decides to require pre-approval procedures for
advertising, skills in screening materials will come in handy.
Confidence in managing industry influence is also a desirable trait that is
needed. Even the ability to understand the entire workflow of FDA and being
able to partner with their colleagues is a skill that can work wonders in a
regulatory environment. There may be existing mechanisms that need not be
reinvented, only enhanced such that activities within the agency can be done
in tandem and not in silos.
In designing the framework of skill sets needed to complete the organizational
tasks, the issue of having enough human resource will definitely arise. It will
not only be a question of numbers. FDA will need to have a human resource
management structure that will enforce competence, loyalty and integrity
among its officers.
131
132
Kenneth Hartigan-Go (2010). Regulatory Reforms. Acta Medica Philippina. Volume 44 No 4. Oct Dec 2010.
FDA Memorandum Circular No 2013 - 028
38
On top of these, there are two overarching matters that will need to factor in
the proposal to improve the organizational structure of FDA. One is the
environment that will encourage innovative solutions among its mangers in
particular. The pharmaceutical industry hires very creative professionals and
government could not fall behind in their strategy to effectively manage the
flow of information on medicines directed to the public and healthcare
professionals.
Another consideration is the ability of the organization to demonstrate and
communicate that their activities are not conducted independently.
Regulation of medicine promotion and advertisement is not a stand-alone
policy it has to be aligned (and therefore well supported with resources) to
FDAs mission and vision. FDA exists to govern the marketplace towards
making medicine safe and accessible. Stakeholders must consistently get this
message in whatever FDA is doing.
Improvement of financing support

In order to implement and enforce the law, government needs to have
adequate funding for the resources that it will need. According to the law,
FDA has several sources of funding: from the General Appropriations Act,
from the fees it collects, and grants from funding agencies. With appropriate
funding, FDA will be in the position to enforce the requirements for therapeutic
equivalency, for instance.
However, FDA is still in the process of working this out.
There are two aspects that FDA can consider regarding the issue of finances.
First is with regards to the extraction of fees and second is in shifting the
purchasing power towards its favor.
In extracting fees, stakeholders need to support this move so that compliance
is ensured. The industry expressed its support to FDA but they would also
need the assurance of transparency and rationality in the manner by which
fees are collected and used.
This review further shows that one of the eventualities affecting procurement
of medicine is the purchasing power of consumers. When it is the consumers
that pay, they could decide to follow what they prefer even if its contrary to
what their doctors advise. At the systems level, PhilHealth, the largest
purchaser of services in the country could be a partner in shifting the
purchasing power in favor of rational drug use. Admittedly, even with
PhilHealth, out of pocket expense remain high, so the impact of harnessing
PhilHealths resources may not be as big initially but it can be a start. In the
attempt to discuss this issue with PhilHealth, the target key informant said that
PhilHealth does not make decisions in the selection of medicine for
reimbursement but rather they just follow what DOH prescribes. This can be
an area of discussion between FDA and PhilHealth so they can both use their
internal mechanism complementarily.
Example, PhilHealth has health
39
technology assessment that can also be use in the rational selection of drugs
that will be reimbursable through its system.
Installation of reliable information technology and management structure

Information is key in regulating the promotion and advertisements of
medicine. However, information is everywhere and regulation can become
very expensive if there is no strategy and infrastructure that could properly
identify where government needs to intervene.
FDAs information structure and management will have to be strategically
placed and linked with that of DOH. Investment should be able to yield
information that will be helpful in managing the control knobs identified in its
regulatory framework and accompanying guidelines. The information pathway
that this infrastructure will create must for instance be able to provide access
to the rules and regulation that is understandable to all its stakeholders.
Information on enforcement and monitoring mechanism must also be clear
such that those who file reports would experience that these are properly
processed.
Importantly, the information structure must also be able to track results not
just on the output of the regulation per se but also on the actual impact on
patients. One example is in encouraging the use of generics. While the law is
already in place, and uptake to this practice is increasing, government still has
to properly track outcomes. Evidence that is properly generated can be a
powerful tool that can tighten up the regulatory wheel and help government
decide on the best way to use its resources.
Improving on the mechanism to harness partnerships

Regulation is probably one of the most difficult and challenging government
function. With resource constraints and the enormity of expectation from FDA,
it could seriously study how to maximize existing linkages and partnerships.
Civil society organizations, patient groups, and local government units are
potential partners.
5.2
Importance of strong and effective government regulation
Strengths of the Regulatory Framework

Stakeholders concur that the presence of a regulatory framework that describes
FDAs mandate and legal reach is the main strength. In this framework, there is a
clear and strong message about prioritization of generics in advertisement and
promotion.
Some level of self-regulation augments the existing mechanism. The current
leadership is also cited as a positive factor that gives strength to the regulatory
structure.
40
Weakness / Gaps of the Regulatory Framework

Mapping the existing documents that support national regulation of medicine
promotion showed that the framework is silent on specific guidance on interactions
between the industry and healthcare practitioners. The recent decision of FDA to
adopt the Mexico City Principles is a step forward to closing this gap as this provides
a more detailed guidance in the said issue.
Stakeholders are unanimous in citing the level of FDA capacity to detect, decide and
act on violations as a cause of concern. This factors into the perceived inefficient
regulation of medicine promotion. FDA is also unable to effectively influence the
interaction of doctors and the pharmaceutical industry.
Majority of the stakeholders identify the internal organization and bureaucratic
structure of FDA as a significant factor affecting performance. Making the regulatory
framework function will require FDA to be appropriately organized and supported but
this is not the case. For example, they could not yet retain their income that could be
used to augment their financial resources. Another evidence is the scant number of
lawyers to process decisions, which is critical in a regulatory agency. FDA is also
perceived to be doing many things and covering a scope of work that could be larger
than what it is able to do.
Role and Extent of Self-regulation
PHAPs Code governing the self-regulation among its members is extensive but
covers only prescription medicine. It has specific provision from general advertising
down to the personal interaction of the industry with health care providers. PHAP
even implements an accreditation program of medical representatives through the
Medical Representatives Accreditation Program (MRAP) that is a step forward to
ensure ethical and professional behavior during product presentation and promotion.
From 2007 to 2011, PHAP Ethics Committee processed less than 10 cases a year,
with less than 5 on 2011. 133 Top violation and penalties refer to clauses on
interaction with healthcare providers: clinical trial / post-marketing studies, continuing
medical education, and discount cards. In 2011, PHAP received 20 or so inquiries
with majority deals with relationship with healthcare providers such as sponsorship
to CMEs, donation of appliances to clinics, adjustment of investigators fee for the
conduct of post-marketing surveillance and gift giving during holiday season.
PCPI, another group of industry players is still in the process of completing their own
Code.
5.3
Impact and Effectiveness of Regulation
The general sense is that the level of regulation is not able to effectively control the
nature of pharmaceutical promotion to abide by recommended standards. Without a
well-defined measure of effectiveness and impact it will be difficult to provide an
133
PHAP Ethics Cases and Rulings. http://www.phap.org.ph/sub.php?id=8&sid=30
41
exact description of such. It would be ideal in the future to set actual metrics that will
measure how regulation impacts patient well-being.
5.4 The use of the HAI/MeTA Tool as a way to investigate the regulatory
framework
The data collection tool is self-explanatory but very detailed and tends to be
repetitive. The tool is a useful form to compare the extent of coverage of one
law/guideline/ policy from each other. It covers more regulatory domains than what
is included in the WHO Ethical Guide for Medicinal Drug Promotion. It provides a
useful start in assembling information that could be processed later on for more
analytic depth. As a tool that meticulously curates information from available
literature, the categories of information may not be easily linked to specific policy
areas for action. One possible configuration that could be considered is designing a
suggested area of health system component that the information gathered is linked
to is it supposed to feed into assessment and recommendation on governance,
financing, etc. This could assist in coming up with a succinct analysis with a health
systems perspective of the overall picture that the tool facilitated to assemble.
Finally, just by using the tool, the impact of regulation may not be discerned.
Regulating the promotion of medicines is supposed to eventually impact prescribing
and buying behaviors but the tool does not have features to measure this aspect.
This may require a separate data-gathering instrument and methodology (e.g,
survey) that could gauge how medicines are actually prescribed, dispensed and
utilized at points of care. In the discussion section above, it is suggested that FDA
installs a mechanism to tract these activities as results could also provide a picture
of FDAs performance in many aspects, not just in regulating information flow on
medicines.
6.0
CONCLUSION
Investing in regulating the promotion and advertisements in medicine is justified by

the desire to protect rational prescribing, dispensing and use of medicines in the
Philippines. In a generation when information can be accessed almost everywhere,
regulation can become more challenging. It will require strategies that are
appropriate to the current environment but also be able to adapt as information and
technology are evolving quickly.
FDAs regulatory framework on the promotion and advertisement of medicine will
have to be strengthened to further reduce information bias from the pharmaceutical
industry, to reduce the reliance of the public and healthcare professional to
information generated by the industry, and to foster a professional environment
between the industry and healthcare professional that will positively influence
rational prescribing, dispensing and utilization.
There are two main suggestions for FDA generated from this review. First is crafting
a Guideline that will clarify ambiguities in the rules. The Guideline has to be
42
applicable and enforceable to all industry players. Self-regulation must be aligned to

the guidance provided by government.
The second recommendation focused on prioritizing the strengthening of FDA as a
regulatory, implementing, monitoring and enforcing agency. The work is immense
and FDA must be organized, funded, and equipped to do its job, track results, and
communicate its progress to stakeholders. Even in an environment where some
companies practice self-regulation, the large portion of pharmaceutical marketplace
remains unchecked. It is not sufficient that rules are defined in a regulatory
framework. The machinery to implement it must be so designed and equipped to be
able to put the framework into action.
7.0
REFERENCES
ADBOARD. 2006. Standards of Trade Practices and Conduct in the Advertising Industry. 4th
Revision. Available at
http://adboard.amplified360.com/sites/default/files/STANDARDS%20OF%20TRADE%20PR
ACTICES%20%26%20CONDUCT%20MANUAL.pdf
Asia Pacific Economic Cooperation. 2011. The Mexico City Principles for Voluntary Codes of
Business Ethics in the Biopharmaceutical Sector.
http://www.phap.org.ph/files/ethics/Mexico-City-Declaration.pdf
BFAD Regulation No. 5 s. 1987 Guidelines on Advertisement and Promotions of
Prescription Pharmaceutical Products
DOH Administrative Order No 51 series 1988 Implementing Guidelines for Department of
Health Compliance with Republic Act 6675 (Generics Act 1988)
DOH Administrative Order No 62 series 1989 Rules and Regulations to Implement
Prescribing Requirements under the Generics Act of 1988 (RA 6675); Amended in DOH AO
76 s 1989; Amendment in DOH AO 40 s 1990 Amendment to AO 62 s1989 re: Rules and
Regulations to Implement Prescribing Requirements
DOH Administrative Order No 63 s 1989 Rules and Regulations to Implement Dispensing
Requirements under the Generics Act of 1986 (RA 6675); Amended in DOH AO no 77 s
1989
DOH. Administrative Order No 65 s. 1989. Guidelines on Advertisement and Promotions to
Implement the Generics Act of 1988.
DOH AO No. 69 s 1989 Amendment to AO No 65 re: Guidelines on Advertisement and
Promotions to Implement the Generics Act of 1988
DOH Administrative Order No 2013 0021 Adoption of the Association of Southeast Asian
Nations (ASEAN) Common Technical Dossier (ACTD) and Common Technical
Requirements (ACTR) for the Registration of Pharmaceutical Products for Human Use
DOH AO No 169 s 2004 Implementing Guidelines for the Exclusive Use of Generic Names
or Generic Terminology in all Prescriptions and Orders in all DOH Facilities
43
DOH. Department Circular No. 2011-0101. The Rules and Regulations Implementing
Republic Act No. 9711 The Food and Drug Administration Act of 2009.
Executive Order 174 Further Amending Republic Act 5921, Entitled An Act Regulating the
Practice of Pharmacy and Setting Standards of Pharmaceutical Education in the Philippines
and for other Purposes as Amended. (1987)
Executive Order 175 Further Amending Republic Act No. 3720 An Act to Ensure the Safety
and Purity of Foods, Drugs, and Cosmetics Being Made Available to the Public by Creating
the Food and Drug Administration Which Shall Administer and Enforce the Laws Pertaining
Thereto, as Amended and for other Purposes. (1987)
Food and Drugs Authority website. www.fda.gov.ph
FDA Circular No 2013-024 Adoption and Implementation of The Mexico City Principles for
Voluntary Codes of Business Ethics in the Biopharmaceutical Sector
FDA Memorandum Circular No 2013-028 General Guidelines on the Promo Permit
Applications and for other Purposes
International Federation of Pharmaceutical Manufacturers & Association. 2012. Code of
Practice. http://www.phap.org.ph/files/ethics/IFPMA_Code_of_Practice_2012.pdf
Memorandum Order No. 133 Directing the Secretary of Health to Properly Implement the
National Drug Policy Set Forth in Executive Orders Nos. 174 and 175.
National Statistics Office (2009). Family Income Expenditure Survey 2009
Pharmaceutical & Healthcare Association of the Philippines. 2013. Code of Practice.
http://www.phap.org.ph/files/ethics/PHAP-Code-Of-Practice.pdf
Pharmaceutical & Healthcare Association of the Philippines. 2012. Factbook 8th ed, August
2012. Accessed at http://www.phap.org.ph/files/ethics/PHAP-Factbook.pdf
Philippine Medical Association. 2008. Code of Ethics of the Philippine Medical Association.
https://www.philippinemedicalassociation.org/downloads/pma-codes/FINAL-PMACODEOFETHICS2008.pdf
Republic Act 3720 Food, Drugs and Devices and Cosmetics Act (1963)
Republic Act 3720. Food, Drug and Cosmetics Act as Amended by Executive Order No 175
(1987)
Republic Act 6675. Generics Act of 1988
Republic Act 7394 The Consumer Act of the Philippines (1991)
Republic Act 8424 Tax Reform Act of 1997
Republic Act 9711. An act strengthening and rationalizing the regulatory capacity of the
bureau of food and drugs (BFAD) by establishing adequate testing laboratories and field
offices, upgrading its equipment, augmenting its human resource complement, giving
authority to retain its income, renaming it to the food and drug administration (FDA),
amending certain section of republic act no. 3720, as amended and appropriating funds
thereof.
44
Roberts, Marc et al. (2004). Introduction to Health Care Regulations IN: International
Comparative Review of Health Care Regulatory Systems. New York: Oxford University
Press, Inc
Sheikh, Kabir, Prasanna Saligram, and Lakshmi E. Prassad. 2013. Mapping the regulatory
architecture of for health care delivery in mixed health systems in low-and middle-income
countries. Melbourne, Australia: Nossal Institute for Global Health
Wazana, A. 2000. Physicians and the pharmaceutical industry: is a gift ever just a gift?
JAMA 283 (3): 373-80.
World Health Organization. 1998. Ethical criteria for medicinal drug promotion. Geneva.
http://apps.who.int/medicinedocs/documents/whozip08e/whozip08e.pdf
45
Annex A1. Interview Schedule: Key Informant from Drug Regulatory

Authorities
Country
Date and Location
Recording
Yes
No
INTERVIEWEE
FULL NAME:
TITLE AND AFFILIATION:
E-MAIL:
ADDRESS:
PHONE NUMBER:
INTERVIEWER
FULL NAME:
E-MAIL:
REMARKS:
46
General introduction:
The purpose of this interview is to gather information on the regulatory system in
your country concerning medicines promotion. In many countries this is a grey area,
there is little awareness about the legislation, what is authorized and what is not.
We want to learn more about the regulatory framework, but we also want to know
what are the promotional practices used in Philippines to advertise medicines. The
goal is to identify problems and best practices by gathering information in multiple
countries. We review the legislation and interview key stakeholders, such as Drug
Regulatory Authorities, healthcare professionals, civil society, the pharmaceutical
industry, etc. With this, we hope to provide recommendations to strengthen
regulatory systems to improve medicines use and public health in general. After the
assessment in your country will be carried out, we will get back to you with the
findings.
Did you see the fact sheet on the project? Do you have questions about it?
First of all, I would like you to introduce yourself and to talk to me briefly about the
main areas you focus on in your work.
Do you think you are the right person I should talk to in order to learn more about
promotional practices?
If not, could you let me know of other people you think might be able to provide
valuable contribution?
47
1. Does the government provide or support independent information on medicines

to health care professionals and/or consumers?
2. What do you think of the content of advertisements for medicines in general? Do
you think that information in advertisements is consistent with the actual product
characteristics?
3. Are prescription-only medicines advertised to the public? In which ways? Are
there disease awareness campaigns in your country? Do they display brand
names?
4. Are consumers exposed to advertisements from other countries? Which
countries? Through which media? Are they different from advertisements from
your country? How?
5. What is the implication of the ASEAN Common Technical Document to the
promotion of medical products?
6. What is the way forward to ensure compliance with The Mexico City Principles?
7. Do doctors or pharmacists receive discounts, rebates or bonuses as an incentive
to prescribe and dispense more?
8. Are medicines prescribed by brand or generic name? Does it vary between
sectors (public and private)? How?
9. Are medicines promoted and/or prescribed apart from the registered indications
for that particular product?
10. Is generic substitution allowed? Who is allowed to substitute? Is it done in actual
practice? What do patients think about it?
11. Who is involved in the process by which medicines are selected to be supplied
and/or reimbursed? What is the influence of pharmaceutical companies?
12. Do patient organizations advocate for specific medicines to be registered or
reimbursed in your country? Who funds these organizations?
13. Are medicines sold informally on the (black) market, in kiosks? Are those
activities monitored? By whom?
Does the pharmaceutical industry have an official role in the regulation of drug
promotion? Which sort of role? If the industry self regulates its promotional
activities, does the government have an oversight on the mechanism? How? If
not, do you think it has an informal role? How?
14. What proportion of the promotional material is approved when going through the
pre-approval process (if applicable)?
48
15. Are there concerns about promotional activities? Who is taking action?
Consumers? Industry competitors? Do you know of formal complaints being
filed? What was the outcome? What do you think of the complaint mechanism?
16. Are there penalties against offenders? How many penalties were applied in the
last five years? Can you give examples? Are they published? Do the sanctions
deter future violations? If not, why?
(Clarify the sanctions and penalties stipulated by law)
(Ask for a recent case)
17. How is data on violations collected? (Active vs Passive)
18. Can you describe the complaints system? How effective is it?
19. How are staffs recruited? How is a potential conflict of interest managed?
20. Are staffing roles clear? Is there an assessment on how effective staffs are in
fulfilling their roles?
21. What is your personal experience in performing your task in regulating medicines
promotion?
22. Are there different staffing complements responsible for (a) defining the
regulatory framework, (b) monitoring, and (c) enforcement?
23. What do you think of the budget and staffing allocated to the regulation of drug
promotion is sufficient?
(How much and from which source?)
24. What can you say about the capacity of your organization in performing your task
as regulators?
(For PHAP): What can you say about the reach of your regulation relative to the
size of the pharmaceutical industry in the country?
25. Who are the other stakeholders involved in regulation? What and how is your
agencys relationship with them?
26. In your opinion what are the main strengths in the control of drug promotion in
your country?
27. In your opinion what are its main weaknesses?
28. Have important development affecting drug promotion regulation taken place
during the past few years? Are there important upcoming events which will likely
influence medicine promotion regulation in your country or region? Please
describe them.
49
29. What is the first thing you would do if you were in a position to change the
regulatory situation on medicine promotion?
30. Is there a national law describing specific provisions guiding how interactions
between the pharmaceutical industry and medical practitioners?
50
Annex A2. Interview Schedule: Healthcare Professional Informant

Country
Date and Location
Recording
Yes
No
INTERVIEWEE
FULL NAME:
E-MAIL:
ADDRESS:
PHONE NUMBER:
INTERVIEWER
FULL NAME:
E-MAIL:
REMARKS:
51
findings.
52
31. Where do healthcare professionals usually go for information on medicines? Are

there sources of independent information? Which sources do you use? How do
you know about them?
32. What do you think of the content of advertisements for medicines in general? Do
you think that information in advertisements is consistent with the actual product
characteristics?
33. Do healthcare professionals use treatment guidelines? Who is involved in their
development? On which basis?
34. Are medicines promoted for uses outside of approved indications? Which ones?
Do you have examples?
35. Do companies sponsor professional development such as scientific events or
Continuing Medical Education? Do sponsors have a role in choosing the
speakers or setting the agenda?
36. What is the usual process to have a medicine added to a hospital formulary? Do
you think medicines promotion influences this process? In what way?
37. What information is given to patients when medicines are dispensed? (Package
inserts and labeling available)
names?
40. Do patients request for specific brands of medicines? How much influence does it
have on prescribing practices?
41. Are prescription medicines available over the counter? Is this a widespread
phenomenon? (What proportion of sales?)
43. Are you exposed to advertisements from other countries? Which countries?
Through which media? Are they different from advertisements from your country?
How?
45. Is generic substitution allowed? Who is allowed to substitute? Is it done in actual
practice? What do patient think about it?
53
46. What is the relationship between health care professionals (doctors, pharmacists,
others) and pharmaceutical companies?
47. Do doctors or other health professionals receive gifts from medicine providers or
producers? What kinds of gifts are most common? What do you think of this
practice?
48. Do doctors receive free samples of medicines? How many free samples of
medicines do doctors receive on average in a month? What do you think about
this practice?
49. Do doctors or pharmacists receive discounts, rebates or bonuses as an incentive
to prescribe and dispense more?
Healthcare professionals? Consumers? Industry competitors? Do you know of
formal complaints being filed? What was the outcome? What do you think of the
complaint mechanism?
51. Are there penalties against offenders? Are they published? Do the sanctions
deter future violations? If not, why? Is corrective information given to healthcare
professionals? Give examples.
52. In your opinion what are the main strengths in the way medicines promotion is
regulated in your country?
54. Have important developments affecting drug promotion regulation taken place
during the past few years? Are there important upcoming events which will likely
influence medicine promotion regulation in your country or region? Please
describe them.
54
Annex A3. Interview Schedule: Pharmaceutical Industry, the

Insurers, and the Media
Country
Date and Location
Recording
Yes
No
INTERVIEWEE
FULL NAME:
E-MAIL:
ADDRESS:
PHONE NUMBER:
INTERVIEWER
FULL NAME:
E-MAIL:
REMARKS:
55
findings.
56
1.
What do you think of the content of advertisements for medicines in general?

Do you think that information in advertisements is consistent with the actual
product characteristics?
2.
Do patients request for specific brands of medicines? How much influence

does it have on prescribing practices?
3.
Do doctors or pharmacists receive discounts, rebates or bonuses as an

incentive to prescribe and dispense more?
4.
Are prescription-only medicines advertised to the public? In which ways? Are

names?
5.
Are prescription medicines available over the counter? Is this a widespread

6.
Are medicines sold informally on the (black) market, in kiosks? Are those
7.
promotion? Which sort of role? If the industry self regulates its promotional
activities, does the government have an oversight on the mechanism? How?
If not, do you think it has an informal role? How?
8.
Do patient organizations advocate for specific medicines to be registered or

9.
Who is involved in the processes by which medicines are selected to be

supplied and/or reimbursed? What is the influence of pharmaceutical
companies?
10.
Are medicines prescribed by brand or generic name? Does it vary between

11.
Is generic substitution allowed? Who is allowed to substitute? Is it done in

actual practice? What do patient think about it?
12.
Do companies sponsor professional development such as scientific events or

13.
Are medicines promoted for uses outside of approved indications? Which

ones? Do you have examples?
14.
Does the pharmaceutical industry have a standard of how much spending is

allowed for advertising / promoting of medical products? Is this information
reported to the public domain?
57
15.
Are there concerns about promotional activities? Who is taking action?

formal complaints being filed? What was the outcome? What do you think of
the complaint mechanism?
16.
In your opinion what are the main strengths in the way medicines promotion is
17.
In your opinion what are its main weaknesses?
18.
Have important developments affecting drug promotion regulation taken place

during the past few years? Are there important upcoming events which will
likely influence medicine promotion regulation in your country or region?
Please describe them
19.
What is the first thing you would do if you were in a position to change the
58
Annex A4. Interview Schedule: Civil Society Organization or Patient

Group or WHO Country Office
Country
Date and Location
Recording
Yes
No
INTERVIEWEE
FULL NAME:
E-MAIL:
ADDRESS:
PHONE NUMBER:
INTERVIEWER
FULL NAME:
E-MAIL:
REMARKS:
59
findings.
60
1. Where do consumers usually go for information on medicines? Are there

sources of independent information? Which sources do you use? How do you
know about them?
2. What do you think of the content of advertisements for medicines in general?
Do you think that information in advertisements is consistent with the actual
product characteristics?
3. Are consumers exposed to advertisements from other countries? Which
countries? Through which media? Are they different from advertisements from
your country? How?
4. What is the relationship between health care professionals (doctors,
pharmacists, others) and pharmaceutical companies?
5. Do doctors or other health professionals receive gifts from medicine providers
or producers? What kinds of gifts are most common? What do you think of
this practice?
6. Do doctors receive free samples of medicines? What do you think about this
practice?
7. Do doctors or pharmacists receive discounts, rebates or bonuses as an
incentive to prescribe and dispense more?
8. Who is involved in the processes by which medicines are selected to be
supplied and/or reimbursed? What is the influence of pharmaceutical
companies?
10. Do companies sponsor professional development such as scientific events or
12. Are prescription medicines available over the counter? Is this a widespread
13. Are medicines promoted for uses outside of approved indications? Which
ones? Do you have examples?
names?
61
16. Is generic substitution allowed? Who is allowed to substitute? Is it done in
actual practice? What do patient think about it?
formal complaints being filed? What was the outcome? What do you think of
the complaint mechanism?
18. Are there penalties against offenders? Are they published? Do the sanctions
deter future violations? If not, why?
19. Are consumers/civil society organizations involved in regulating promotion?
promotion? Which sort of role>
20. If the industry self regulates its promotional activities, does the government
have an oversight on the mechanism? How? If not, do you think it has an
informal role? How?
21. In your opinion what are the main strengths in the way medicines promotion is
23. Have important developments affecting drug promotion regulation taken place
during the past few years? Are there important upcoming events which will
likely influence medicine promotion regulation in your country or region?
Please describe them
62
Annex B. Inventory of documents reviewed with provisions on

regulating medicine promotion
Legislative Documents
1. Medicines regulation law/act
Republic Act 6675 Generics Act of 1988.
o Supported by: DOH Administrative Order No 51 series 1988 Implementing
Guidelines for Department of Health Compliance with Republic Act 6675
(Generics Act 1988)
o Supported by: DOH Administrative Order No 62 series 1989 Rules and
Regulations to Implement Prescribing Requirements under the Generics Act
of 1988 (RA 6675); Amended in DOH AO 76 s 1989; Amendment in DOH AO
40 s 1990 Amendment to AO 62 s1989 re: Rules and Regulations to
Implement Prescribing Requirements
o Supported by: DOH Administrative Order No 63 s 1989 Rules and
Regulations to Implement Dispensing Requirements under the Generics Act
of 1986 (RA 6675); Amended in DOH AO no 77 s 1989
o Supported by: DOH AO No 169 s 2004 Implementing Guidelines for the
Exclusive Use of Generic Names or Generic Terminology in all Prescriptions
and Orders in all DOH Facilities
DOH Administrative Order No. 65 s1989 Guidelines on Advertisement and
o Supported by: DOH AO No. 69 s 1989 Amendment to AO No 65 re:
Guidelines on Advertisement and Promotions to Implement the Generics Act
of 1988
Republic Act 3720 Food, Drugs and Devices and Cosmetics Act as amended
by Executive Order No 175 (1987)
Republic Act 9711 Food and Drug Administration Act of 2009
o Supported by: DOH Department Circular No 2011-0101 The Rules and
Regulations Implementing Republic Act No 9711-The Food and Drug
Administration Act of 2009
BFAD Regulation No. 5 s. 1987 Guidelines on Advertisement and Promotions of
Prescription Pharmaceutical Products
FDA Circular No 2013 024 Adoption and Implementation of The Mexico City
Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical
Sector
o Supported by: The Mexico Principles for Voluntary Codes of Business Ethics
in the Biopharmaceutical Sector
National Medicines Policy
Executive Order 174 Further Amending Republic Act 5921, Entitled An Act
Regulating the Practice of Pharmacy and Setting Standards of Pharmaceutical
Education in the Philippines and for other Purposes as Amended. (1987)
Executive Order 175 Further Amending Republic Act No. 3720 An Act to Ensure
the Safety and Purity of Foods, Drugs, and Cosmetics Being Made Available to
the Public by Creating the Food and Drug Administration Which Shall Administer
and Enforce the Laws Pertaining Thereto, as Amended and for other Purposes.
(1987)
63
Memorandum Order No. 133 Directing the Secretary of Health to Properly

Implement the National Drug Policy Set Forth in Executive Orders Nos. 174 and
175.
2. Supranational / regional agreements
ASEAN Common Technical Document / APEC Declaration for Ethical Marketing
of Bio-Pharmaceuticals
o Concurred nationally through DOH Administrative Order No 2013 0021
Adoption of the Association of Southeast Asian Nations (ASEAN) Common
Technical Dossier (ACTD) and Common Technical Requirements (ACTR) for
the Registration of Pharmaceutical Products for Human Use
3.
4.
5.
6.
Sub-national policies/laws
Advertisement law
Commerce law
Consumer protection law
Republic Act 7394 The Consumer Act of the Philippines (1991)
7. Other
WHO Ethical Criteria for Medicinal Drug Promotion (1988)
Republic Act 8424 Tax Reform Act of 1997
Self- Regulation
1. Pharmaceutical industry code(s)
Pharmaceutical and Healthcare Association of the Philippines (PHAP) Code of
Practice (2013)
2. Related procedures for enforcement
3. Advertising industry code
ADBOARD Standards of Trade Practices and Conduct in the Advertising Industry
Others
1. Procedures for
- obtaining pre-approval of advertisements for medicines
FDA Memorandum Circular No 2013-028 General Guidelines on the Promo
Permit Applications and for other Purposes
-
complaining about medicines promotion

sanctions and enforcement
64

Republic Act 6675 Generics Act of 1988.
2. Annual reports / descriptive material on the work of regulatory authorities on
promotion
3. List of institutions or departments involved in promotion regulation and the areas the
cover (organigram)
Organization Structure of Food and Drug Administration
4. Number of staff involved in promotion regulation and their positions (organigram)
5. Description of activities the bodies involved in promotion regulation
Republic Act 3720 Food, Drugs and Devices and Cosmetics Act as amended
by Executive Order No 175 (1987)
Pharmaceutical and Healthcare Association of the Philippines Code of Practice
(2013)
6. Conflicts of interests policies of the bodies involved in promotion regulation
Republic Act 9711 Food and Drugs Administration Act of 2009
7. Published research on promotion in the country
8. Other relevant policies / regulation from
- Professional associations
Code of Ethics of the Philippine Medical Association
-
Medical schools
Hospitals
Scientific offices
65
Annex C. Document Checklist

This checklist is indicative and aims at helping the researcher in his work by giving indicators as to which documents might be relevant to
medicines promotion and control. Many countries might have only few of these documents available. The material found shall be used as
support to answer the questions in the data compilation part.
Document
Exist /
does
not
exist
Name of the document

and date
Medicines
regulation
law / act
Exist
Republic Act 6675

Generics Act of 1988
DOH Administrative
Order No. 51 series
1988 Implementing
Guidelines for
Department of Health
Compliance with
Republic Act 6675
(Generics Act of 1988)
DOH Administrative
Order No 62 s 1989
Rules and Regulations
to Implement
Prescribing
Requirements under the
(RA 6675)
DOH Administrative
Source (if available on the internet, please include URL)
Reas
on, if
not
provi
ded
Legislative documents
Website of the Food and Drug Administration
http://www.fda.gov.ph/issuances/29035-repubic-act-no-6675-generic-act-of-1988
http://old.fda.gov.ph/AO/ao%2051%20s%201988.pdf
Website of the Food and Drugs Administration

66
Order No 63 s 1989
Rules and Regulations
to Implement
Dispensing
Requirements under the
(RA 6675)
DOH Administrative
Order No. 65 s. 1989
Guidelines on
Advertisement and
Promotions to
Implement the Generics
Act of 1988
DOH AO 69 s 1989
Amendment to AO No
65 re: Guidelines on
Advertisement and
Promotions to
Act of 1988
Republic Act 3720
Foods, Drugs and
Cosmetics Act (1963)
Republic Act 3720
Foods, Drugs and
Devices, and Cosmetics
Act as amended by
Executive Order 175
(1987)
Republic Act 9711
Food and Drug
Administration Act of
2009
DOH Department

Website of the Department of Health

http://home.doh.gov.ph/ais_public/aopdf/ao_backup/ao/htm_bkup/ao_all.htm
Website of The LAWPhilProject, Arellano Law Foundation, Philippine Laws and

Jurisprudence Databank
http://www.lawphil.net/statutes/repacts/ra1963/ra_3720_1963.html
http://www.fda.gov.ph/attachments/article/29032/RA%203720.pdf

http://old.fda.gov.ph/republic%20acts/RA%209711BFAD%20Strengthening%20Law.pdf
67
National
Medicines
Policy
Exist
Circular No 2011-0101
The Rules and
Regulations
Implementing Republic
Act No 9711-The Food
and Drug Administration
Act of 2009
BFAD Regulation No. 5
s. 1987 Guidelines on
Advertisement and
Promotions of
Prescription
Pharmaceutical
Products
FDA Circular No 2013
024 Adoption and
Implementation of The
Mexico City Principles
for Voluntary Codes of
Business Ethics in the
Biopharmaceutical
Sector
The Mexico City
Principles for Voluntary
Codes of Business
Ethics in the
Biopharmaceutical
Sector
Executive Order
Number 174
http://old.fda.gov.ph/Department%20Circular/IRR%20of%20RA%209711.pdf
Executive Order
Number 175
Memorandum Order No
133
http://old.fda.gov.ph/republic%20acts/eo%20175.pdf

http://www.fda.gov.ph/attachments/article/103511/Fda%20Circular%20No.2013024%20Adoption.......new.pdf
Website of PHAP:
http://www.phap.org.ph/files/ethics/Mexico-City-Declaration.pdf

http://www.fda.gov.ph/attachments/article/29033/eo%20174.pdf

http://www.gov.ph/downloads/1987/11nov/19871118-MO-0133-CCA.pdf
68
If relevant,
provisions
pertaining to
medicines
promotion in:
Supranation
al / regional
agreements
Sub national
policies /
laws
Advertiseme
nt law
Commerce
law
Consumer
protection
law
Other
(guidelines,
codes)
Pharmaceuti
cal industry
code (s)
Advertising
agency
Exist
ASEAN Common
Technical Document /
APEC Declaration for
Ethical Marketing of BioPharmaceuticals
Exist
Republic Act 7394 The

Consumer Act of the
Philippines (1991)
Medicinal Drug
Promotion (1988)
Republic Act 8424 Tax
Reform Act of 1997
Exist
Exist
Exist
Pharmaceutical and
of the Philippines Code
of Practice (2013)
Code of Ethics of the
Philippine Medical
Association
ADBOARD Standards
of Trade Practices and

http://dtincr.ph/files/LawsAndPolicies-ConsumerAct.pdf
Website of the World Health Organization
http://apps.who.int/medicinedocs/en/m/abstract/Jwhozip08e/
Website of the Bureau of Internal Revenue
http://www.bir.gov.ph/taxcode/taxcode.htm
Self - Regulation
Website of Philippine Healthcare Association of the Philippines
http://www.phap.org.ph/sub.php?id=4&sid=18
Website of the Philippine Medical Association

Website of ADBOARD
http://adboard.amplified360.com/sites/default/files/STANDARDS%20OF%20TRAD
69
industry
code
Conduct in the
Advertising Industry
(2006)
E%20PRACTICES%20%26%20CONDUCT%20MANUAL.pdf
Related
procedures
for
enforcement
Other Relevant Documents
Procedures
for:
-obtaining
pre-approval
of
advertiseme
nts for
medicines
Exist
-complaining
about
medicines
promotion
Exist
-sanctions
and
enforcement
Exist
DOH Administrative
Guidelines on
Advertisement and
Promotions to
Act of 1988
FDA Memorandum
Circular No 2013-028
General Guidelines on
the Promo Permit
Applications and for
other Purposes
DOH Administrative
Guidelines on
Advertisement and
Promotions to
Act of 1988
DOH Administrative
Guidelines on
Advertisement and
Promotions to



70

Act of 1988
Annual
reports/descr
iptive
material on
the work or
regulatory
authorities
on promotion
List of
institutions or
departments
involved in
promotion
regulation
and the
areas they
cover
(organigram)
Number of
staff involved
in promotion
regulation
and their
positions
(organigram)
Description
of activities
the bodies
involved in
promotion
regulation
Exist
Republic Act 3720

Foods, Drugs and
Cosmetics Act (1963)
Website of The LAWPhilProject, Arellano Law Foundation, Philippine Laws and

Jurisprudence Databank
http://www.lawphil.net/statutes/repacts/ra1963/ra_3720_1963.html
Republic Act 3720

Foods, Drugs and

http://www.fda.gov.ph/attachments/article/29032/RA%203720.pdf
71
Conflicts of
interests
policies of
the bodies
involved in
promotion
regulation
Published
research on
promotion in
the country
(GGM/MeTA
/other)
Other
relevant
policies /
regulation
from:
Professional
associations
Exist
Exist
Devices, and Cosmetics

Act as amended by
Executive Order 175
(1987)
Republic Act 9711
Food and Drug
2009
Pharmaceutical and
of the Philippines Code
of Practice (2013)
Republic Act 9711
Food and Drug
2009
Code of Ethics of the

Philippine Medical
Association


Website of the Philippine Medical Association

Medical
schools
72
Hospitals
Scientific
offices
73
Annex D. Data Compilation Tool

Scope of the regulation
Republic Act 6675 Generics Act of 1988
1. What is defined as advertisement?
2. What is defined as promotion?
3. What are the provisions concerning medicines promotion /
It is hereby declared the policy of the State: to promote, encourage
advertisement?
and require the use of generic terminology in the importation,
manufacture, distribution, marketing, advertising and promotion,
prescription and dispensing of drugs. [Section 2]
It is hereby declared the policy of the State: to emphasize the scientific
basis for the use of drugs, in order that health professionals may
become more aware and cognizant of the therapeutic effectiveness
[Section 2]
4. Does it cover traditional medicines, complementary medicines?

How?
5. Do advertisements have to comply with approved product
information/label?
6. Are certain categories of medicines banned from advertising?
Which ones (unregistered medicines, narcotics)?
7. Is advertising to the general public authorized? For which
substances? Through which media?
In the promotion of the generic names for pharmaceutical products,

special consideration shall be given to drugs and medicines which are
included in the Essential Drug List[Section 4]
Drug outlets, including drugstores, hospital and non-hospital
pharmacies and non-traditional outlets such as supermarkets and
stores shall inform any buyer about all other drug products having the
same generic name, together with their corresponding prices so that
the buyer may adequately exercise his optionshall post in
conspicuous places in their establishment a list of drug products with
the same generic name and their corresponding prices (RA 6675 Sec
6.c)
74
8. For which medicines is advertising to health professionals

authorized? Through which media? (e.g. medical journals only?)
9. What information has to be included in an advertisement? Specify
by media type.
To promote, encourage and require the use of generic terminology in

the importation, manufacture, distribution, marketing, advertising and
promotion, prescription and dispensing of drugs (RA 6675, Sec 2)
In the promotion of the generic names for pharmaceutical products,
special consideration shall be given to drugs and medicines which are
included in the Essential Drug List(RA 6675, Sec4)
10. Are requirements for advertising identical for exported and/or

imported medicines and/or locally produced medicines?
11. Are there minimal qualifications listed as necessary to be a
pharmaceutical sales representative? What are they?
Forms of promotion covered: what is written about
12. Gifts/payments to doctors or other health professionals
13. Pharmaceutical sales representatives interaction with
14. Discounts and rebates on medicines
15. Distribution of free medicine samples
16. Sponsorship of Continuing Medical or Pharmacy Education
17. Sponsorship of scientific meetings
18. Information to patients (package insert contents)
19. Packaging and labeling
20. Internet and related social networking media
Any organization or company involved in the manufacture,

importation, repacking, marketing and/or distribution of drugs and
medicine shall indicate prominently the generic name of the product
labels as well as in advertising and other promotional materials (RA
6675 Sec 6.b)
-
In order to assure responsibility of drug quality in all instances, the

label of drugs and medicine shall have the following: name and
country of manufacture, dates of manufacture and expiration. The
quality of such generically labeled drugs and medicines shall be duly
certified by the Department of Health (RA 6675 s7)
-
75
21. Post-marketing studies

22. Clinical trials and promotion
23. Promotion of off-label indications
24. Other

DOH Administrative Order No 51 series of 1988 Implementing Guidelines for Department of Health Compliance with Republic Act 6675
(Generics Act of 1988)
advertisement?
How?
information/label?

All heads of agencies shall take the necessary and sufficient steps to
inform the public about measures to implement RA 6675 and the
rationale for these measures. The Public Information and Health
Education Service at the central office shall produce and disseminate
informational materials necessary to inform the public on these
matters. [DOH AO 51 s1988 14.1 and 14.3]
Heads of agencies, assisted by their respective Therapeutic
Committees, shall plan and undertake promotional activities among
DOH personnel, particularly physicians and nurses. These activities
should (a) clarify the provisions of the law and the implementing
regulations (b) explain the reasons for generic names in drug use; (c)
answer the most common misinformation, apprehensions and
complaints. The central staff for NDP implementation shall organize
and deploy well qualified resource persons for lectures and seminars
on NDP implementation. [DOH AO 51 s1988 15]
76

by media type.
24. Other

DOH Administrative Order No. 65 s1989 Guidelines on Advertisement and Promotions to Implement the Generics Act of 1988
Advertisement any representation by any means whatever for the
purpose of promoting directly or indirectly the sale or disposal of any
pharmaceutical product [Section 1.1]
Promotion 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.
[Section 1.2]
All therapeutic claims for drugs, medicines or any pharmaceutical
advertisement?
product made in advertising or promotional materials must be based
77

How?
information/label?



by media type.
on adequate scientific, pharmacological, and clinical evidence,

responsible medical opinion or long experience demonstrating their
safety, efficacy and therapeutic value, and must be within their
therapeutic indications approved by the BFAD [Section 2.2]
Pharmaceutical products, prescription or ethical drugs, nonprescription drugs / over the counter drugs [Section 1]
Consistent with section 6 ( c ) of RA 6675, all advertising and
promotional materials, whether print, visual or auditory, shall feature
prominently the generic name of the drug product designated by
BFAD. In the case of branded products, the prominence of the generic
name shall be insured in all print, visual or auditory materials that
feature the brand name. No pharmaceutical product classified by
BFAD as a Prescription or Ethical Drug shall be advertised or
promoted in any form of mass media except through medical journals,
publications and/or literature solely intended for medical and allied
professions. [Section 3.1]
No person shall advertise or promote a pharmaceutical product unless
such product is duly-registered by Bureau of Food and Drugs <BFAD>
[Section 2.1]
No pharmaceutical product classified by BFAD as a Prescription or
Ethical Drug shall be advertised or promoted in any form of mass
media except through medical journals, publications and/or literature
solely intended for medical and allied professions. [DOH AO No 65
s1989, Section 2.3]
No pharmaceutical product classified by BFAD as a Prescription or
s1989, Section 2.3]
Consistent with section 6 ( c ) of RA 6675, all advertising and
promotional materials, whether print, visual or auditory, shall feature
prominently the generic name of the drug product designated by
BFAD. In the case of branded products, the prominence of the generic
name shall be insured in all print, visual or auditory materials that
feature the brand name. No pharmaceutical product classified by
78
BFAD as a Prescription or Ethical Drug shall be advertised or

promoted in any form of mass media except through medical journals,
publications and/or literature solely intended for medical and allied
professions. [Section 3.1]
Print and Static Visual Materials (e.g., posters, billboards) the
pertinent provisions of AO 55 s 1988in all cases, the generic name
shall be prominently printed element on the advertising and other
promotional material defined as the one with the highest point size
among the various printed elements on the advertising and other
promotional material. It shall be enclosed exclusively by an outlined
box rendered in the same color as the generic name. The background
color inside the box, against which the generic name is rendered,
should be the same color as the background color outside the box,
against which the brand name is rendered. [Section 3.2]
For other forms of visual materials, such as television, cinema or
movies, etc, the general principle in 3.1 will be applied, and consistent
with AO 55 s. 1988 as amended, the generic name designated by
BFAD shall appear prominently within the outlined box, immediately
above an in larger point-size than the brand name, if any. No
pharmaceutical product classified by BFAD as a Prescription or
s1989, Section 3.3]

For auditory materials used in radio or other media, the general

principle in 3.1 will be adopted according to the convention of the
medium. [Section 3.4]
-
79

24. Other
The pharmaceutical company which owns the pharmaceutical product,

and its Medical Director shall be responsible and accountable for the
content and form of its advertisement and promotional material
(Section 2.4)

Executive Order No. 174 (1987)
advertisement?
4. Does it cover traditional medicines, complementary medicines? Drug means (1) articles recognized in the current official United States
How?
Pharmacopoeia or the United States Official National Formulary (ISPNF), official Homeopathic Pharmacopoeia of the United States, official
National Drug Formulary, or any supplement to any of them; and (2)
articles intended for use in the prevention of disease in man or
animals; (3) articles (other than food) intended to affect the structure
or function of the body of man or animals; and articles intended for
use as a component of any articles specified in clauses (1), (2) or (3)
but do not include devices or their components, parts or accessories.
80

information/label?
by media type.
24. Other
[Section 3]
-

Executive Order 175 (1987)

-
81

advertisement?

How?
Drug means (1) articles recognized in the current official United States
Pharmacopoeia or the United States Official National Formulary (ISPNF), official Homeopathic Pharmacopoeia of the United States, official
National Drug Formulary, or any supplement to any of them; and (2)
articles intended for use in the prevention of disease in man or
or function of the body of man or animals; and articles intended for
use as a component of any articles specified in clauses (1), (2) or (3)
but do not include devices or their components, parts or accessories.
[Section 5]
-

information/label?

by media type.
Section 11 of RA 3720 is amended to read: The following acts and

causing thereof are hereby prohibited:
(k) The manufacture, importation, exportation, sale, offering for sale,
distribution, or transfer of any drug or device by any person without
the license from the Bureau required under this Act
[Section 7]
-
82

24. Other
Section 11 of RA 3720 is amended to read: The following acts and

causing thereof are hereby prohibited:
(h) The use, on the labeling of any drugs or in any advertising relating
to such drug, of any representation or suggestion that an application
with respect to such drug is effective under Section twenty-one and
twenty-one B hereof, or that such drug complex with the provisions of
such actions.
[Section 7]
Section 19 of RA 3720 is amended to read as A drug or device shall
be deemed misbranded: if the labeling is false or misleading in any
particular; if any word, statement or other information required by or
under authority of This Act to appear on the label or labeling is not
prominently placed thereon; unless the labeling bears adequate
directions for use and such adequate warning against use in those
pathological conditions or by children; [Section 11]
-

Memorandum Order No 133
advertisement?
83

How?
information/label?
by media type.
24. Other
Wider dissemination of adequate and accurate information on drugs

and medicines to both physicians and the public at large
-

84
BFAD Regulation No 5 s 1987 Guidelines on Advertisement and Promotions of Prescription Pharmaceutical Products (1987)
Any representation by any means whatever for the purpose of
promoting directly or indirectly the sale or disposal of any
pharmaceutical product. [Section 1.a]
The practice of giving temporary additional value to a brand, product,
or service to achieve specific marketing objectives. It includes the
distribution of free/sample pharmaceutical products. [Section 1.b]
No person shall advertise or promote prescription drugs unless such
advertisement?
product is duly registered by the BFAD [Section 2]
How?
information/label?

by media type.
No pharmaceutical product classified by the BFAD as a prescription

drug shall be advertised or promoted in any form or mass media
except through medical journals, publications and/or literature solely
intended for medical and allied profession. [Section 4]
Any change in product presentation, such as change in packaging, of
a prescription drug may be advertised for public information, provided
no medical claims, comparative statements, or promotional messages
are included in the announcement, provided further that the following
statement is always clearly indicated: This pharmaceutical drug
product is approved for sale by BFAD as a prescription drug and
should be bought only with a prescription. [Section 5]
-
85


24. Other
The giving of sample of a prescription drug direct to the lay public is

strictly prohibited. The distribution of free/sample pharmaceutical
products during medical missions and within outpatient dispensaries is
not considered a violation of this provision provided that the
distribution is under the supervision of a physician. [Section 6]
-

FDA Circular No 2013-024 Adoption and Implementation of The Mexico City Principles for Voluntary Codes of Business Ethics in the
Biopharmaceutical Sector
To officially adopt and implement The Mexico City Principles for
advertisement?
Voluntary Codes of Business Ethics in the Biopharmaceutical Sector
[Objectives]
How?
information/label?
86

by media type.
It is essential that professionalism and high ethical standard are

maintained between the biopharmaceutical companies, the health
professionals, and the regulatory body.
[Rationale]

24. Other

The Mexico City Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector
No medicines shall be promoted for use in a specific economy until
87
advertisement?
the requisite approval for marketing for such use has been given in
that economy. Promotion should be consistent with locally approved
product information [Section 2.A]
Promotional information should be clear, legible, accurate, balanced,
fair, objective and sufficiently complete to enable healthcare
professionals to form his or her own opinion of the therapeutic value of
the medicines concerned [Section 2.B]

How?
information/label?
by media type.

12. Gifts/payments to doctors or other healt professionals
For Medical Professionals: Companies have an obligation and

responsibility to provide objective, accurate, balanced information
about their medicines to healthcare professionals[Preamble 5]
Companies should ensure that all representatives who are employed

by or acting on behalf of the companies, and who visit healthcare
professionals, receive training about the applicable laws, regulations
and industry codes of this..ensure that they have sufficient knowledge
of general science and product-specific information [Section 12.A.1]
Payments in cash or cash equivalents (such as gift certificates) or gifts
for the personal benefit of healthcare professionals should not be
provided or offered to healthcare professionals. [Section 7]
Ethical relationships with healthcare professionals, government
officials, patients and other stakeholders are critical to the mission of
Companies to help patients by developing and making medicines
88
available [Preamble 2]
In interacting with all stakeholders, Companies are committed to
following the highest ethical standards as well as all applicable laws
and regulations. [Preamble 3]
All interaction with healthcare professionals are to be conducted in a
professional and ethical manner. [Section 1.C]
1. Healthcare professionals must not be improperly influenced by
Companies.
2. Nothing should be offered or provided by a Company in a
manner that inappropriately influences a healthcare
professionals prescribing practices.
3. Education and promotional activities should encourage the
appropriate use of medicines by presenting them objectively
and without exaggerating their properties, and should be in
compliance with the provisions prescribed by these Principles
and applicable local, national, and regional industry codes of
ethics.
4. Relationships between Company personnel and healthcare
professionals should encourage the development of a medical
practice committed to patients well-being and be based on
truthful, accurate, and updated evidence.
In order to provide important scientific information and to respect
health professionals abilities to manage their schedules and provide
patient care, Company representatives may take the opportunity to
present information during healthcare professionals working day,
including mealtimes, in accordance with applicable laws and
regulations. [Section 5.A]
In accordance with local laws and regulation, samples of medicines

supplied at no charge may be provided to healthcare professionals in
order to enhance patient care. Samples must not be resold or
otherwise misused. [Section 9.B]
89
Financial support is not an inducement to prescribe or recommend a

particular medicine or course of treatment. [Section 8.A.1]
Grants, scholarships, subsidies, consulting contracts, educational or
practice related items should not be provided or offered to a
healthcare professional in exchange for recommending and
prescribing medicines, or otherwise in a manner that would interfere
with the ethics and the independence of a healthcare professionals
prescribing practices. [Section 8.B]
The purpose and focus of all symposia, congresses and other
promotional or non-promotional, scientific or professional meetings (an
Event) for healthcare professionals organized or sponsored by a
Company should be to inform healthcare professionals about products
and/or to provide scientific or educational information. [Section 4]
Any sponsorship provided to individual healthcare professionals must
not be conditional upon an obligation to prescribe, recommend, or
promote any medicine. [Section 4.c]


24. Other
Clinical assessments, postmarketing surveillance and experience

programmes and postauthorization studies must be disguised
promotion. Such assessments, programmes and studies must be
conducted with a primarily scientific or educational purpose. [Section
2.B.4]
Clinical trials should not be used as inappropriate inducements for
past or future sales. [Section 14.B]
Company interactions are professional in nature and are intended to
facilitate the exchange of medical or scientific information that will
benefit patient care. (Referring to entertainment sponsorship) [Section
6]
Companies should continue to ensure that consultant and speaking
arrangements are neither inducements nor rewards for prescribing or
90
recommending a particular medicine or course of treatment. [Section

10.1]
Any compensation or reimbursement made in conjunction with a
consulting or speaking arrangement should be reasonable and based
on fair market value.
Compliance with Public Section Relationship and Procurement laws
[Section 13]
On donations for charitable purposes: companies should ensure that
such support is not undertaken solely for product promotional reasons,
and is not directed solely for product promotion purposesno
incentives to prescribe, recommend, purchase, supply or administer a
product based on financial support [Section 15]
Respect to patient organization autonomy and support must not be
conditional on the promotion of a specific medicine [Section 16]

advertisement?
How?
information/label?
91

by media type.
24. Other

Republic Act 7394 The Consumer Act of the Philippines

Advertising the business of conceptualizing, presenting or making
available to the public, through any form of mass media, fact, data or
information about the attributes, features, quality or availability of
consumer products, services or credit [Art 4.b]
Sales promotion techniques intended for brand consumer
participation which contain promises of gain such as product, security
service or winning in contest, game, tournament and other similar
competitions which involved determination of winner/s and which
utilizes mass media or other widespread media of information. It also
92

advertisement?
means techniques purely intended to increase the sales, patronage

and/or goodwill of a product [Art 1.bm]
Protection against deceptive, unfair and unconscionable sales acts or
practices [Title III]
In general The state shall promote and encourage fair, honest and
equitable relations among parties in consumer transactions and
protect the consumer against deceptive, unfair and unconscionable
sales acts or practices. [Art 48]
In general A deceptive act or practice by a seller or supplier in
connection with a consumer transaction violates this Act whether it
occurs before, during or after the transaction. An act or practice shall
be deemed deceptive whenever the producer, manufacturer, supplier
or seller through concealment, false representation of fraudulent
manipulation, induces a consumer to enter into a sales or lease
transaction of any consumer product or service [Art 50]
Proper labeling of food, drugs, cosmetics and devices [Title III,
Chapter IV]
The State shall enforce compulsory labeling and fair packaging to
enable the consumer to obtain accurate information as to the nature,
quality and quantity of the contents of consumer products and to
facilitate his comparison of the value of such products. [Art 74]
The Generics Act shall apply in the labeling of drugs [Art 86]
The state shall protect the consumer from misleading advertisement
and fraudulent sales and promotion practices [Art 108]
Special Advertising Requirements for Food, Drug, Cosmetic, Device
or Hazardous substance [Art 112]
a. No claim in the advertisement may be made which is not contained
in the label or approved by the concerned department
b. No person shall advertise any food, drug, cosmetic, devise or
hazardous substance in a manner that is false, impression
regarding its character, value, quantity, composition, merit, safety.
c. Where a standard has been prescribed for a food, drug, cosmetic,
or device, no person shall advertise any article or substance in
93

How?
information/label?
by media type.
such a manner that is likely to be mistaken for such product, unless

the article complies with the prescribed standard or regulation.
d. No person shall, in the advertisement of any food, drug, cosmetic,
devise or hazardous substance, make use of any reference to any
laboratory report of analysis required to be furnished to the
concerned department, unless such laboratory report is duly
approved by such department
e. Any businessman who is doubtful as to whether his advertisement
relative to food, drug, cosmetics, device or hazardous substance
will violate or does not conform with this Act or the concerned
departments pertinent rules and regulations may apply to the
same advertisement is disseminated to the public. In this case, the
concerned department gives its opinion and notify the applicant of
its action within thirty (30) days from the date of application,
otherwise, the application shall be deemed approved.
f. No person shall advertise any food, drug, cosmetic, device, or
hazardous substance unless such product is duly registered and
approved by the concerned department for such use in any
advertisement.
Drugs included herbal and / or traditional drug [Article 4.ad]
-
94


24. Other
-Proper labeling of food, drugs, cosmetics and devices [Title III,

Chapter IV]
The State shall enforce compulsory labeling and fair packaging to
enable the consumer to obtain accurate information as to the nature,
quality and quantity of the contents of consumer products and to
facilitate his comparison of the value of such products. [Art 74]
The Generics Act shall apply in the labeling of drugs [Art 86]
-

Republic Act 3720, Food, Drug and Cosmetic Act (1963)
Republic Act 3720, Food, Drug and Cosmetic Act, as Amended
advertisement?
4. Does it cover traditional medicines, complementary medicines? Drug articles recognized in the official United States
How?
Pharmacopoeia, official Homoepathic Pharmacopoeia of the United
States or official National Formulary, or any supplement to any of
them; and (2) articles intended for use in the diagnosis, cure,
95

information/label?
mitigation, treatment, or prevention of disease in man or other

animals; and (3) articles (other than food) intended to affect the
structure or any function of the body of man or animals; and (4)
articles intended for use as a component of any articles specified in
clauses (1), (2), or (3) but not included devices or their components,
parts, or accessories [RA 3720 Section 10]
The following acts and the causing thereof are hereby prohibited: (a)
the manufacture, sale, offering for sale or transfer of any food, drug,
device or cosmetic that is adulterated or misbranded; The use, on the
labeling of any drug or in any advertising relating to such drug, of any
representation or suggestion that an application with respect to such
drug is effective under Section twenty-one hereof (NEW DRUGS), or
that such drug complies with the provisions of such section; the use in
labeling, advertising or other sales promotion of any reference to any
report or analysis furnished in compliance with Section twenty-six
hereof (RA 3720, Section 11)
The manufacture, importation, exportation, sale, offering for sale,
distribution, or transfer of any drug or device which is not registered
with the bureau pursuant to this act [RA 3720, Chapter VI, j]

by media type.
No person shall manufacture, sell, offer for the sale or transfer any
new drug, unless an application filed pursuant to subsection (b) is
effective with respect to such drug [RA 3720 Section 21]
-
96

24. Other

advertisement?
How?
Drug means (1) articles recognized in official pharmacopeias and

formularies, including official homeopathic pharmacopeias, or any
documentary supplement to any of them, which are recognized and
adopted by the FDA; (2) articles intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease in man or other
of any function of the body of humans or animals; or (4) articles
intended for use as a component of any articles specified in clauses
(1), (2) or (3) but do not include devices or their components, parts or
accessories. [RA 9711 Section 10, f]
97

information/label?

by media type.
The following acts and the causing thereof are hereby prohibited: (a)
The manufacture, importation, exportation, sale, offering for sale,
distribution, transfer, non-consumer use, promotion, advertising or
sponsorship of any health product that is adulterated, unregistered or
misbranded; (j) The manufacture, importation, exportation, sale,
offering for sale, distribution, transfer, non-consumer use, promotion,
advertisement, or sponsorship of any health product which, although
requiring registration is not registered with the FDA pursuant to this
Act. [RA 9711 Section 11]
-
98

24. Other

DOH Department Circular 2011-0101
The Rules and Regulations Implementing Republic Act No 9711-The Food and Drug Administration Act of 2009
No health product that has not been registered or authorized shall be
advertisement?
advertised, promoted or subjected to any marketing activities;
No claim in the advertisement, promotion and sponsorship, and other
marketing activities shall be made other than those contained in the
approved label or packaging or the health product, or as duly
approved by the FDA;
No claims, therapeutic or scientific otherwise, shall be made that has
not been duly approved by the FDA;

How?
All health products that are permitted to be promoted must specifically

state the authority or reference number that approved the same
promotional, sponsorship, or marketing activities.
[Article V Section 2]
Drug means
(1) Articles recognized in official pharmacopoeias and formularies,
including official homeopathic pharmacopoeias or any
documentary supplement to any of them, which are recognized
and adopted by the FDA;
(2) Articles intended for use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in man or other animals;
(3) Articles (other than food) intended to affect the structure of any
function of the body of human beings or animals; or
(4) Articles intended for use as a component of any articles
specified in clauses (1), (2), or (3) but do not include devices or
their component, parts or accessories.
99

information/label?
by media type.
24. Other

Pharmaceutical and Healthcare Association of the Philippines (PHAP) Code of Practice (2013)
Advertisement: promotion of a product, service, advocacy or institution
100

advertisement?
by way of paid placement through media (print, broadcast, billboards,

collaterals) at a guaranteed target date and time. This includes any
representation by any means whatever for the purpose of promoting
directly or indirectly the sale or disposal of any pharmaceutical
product. [Appendix]
Promotion the practice of giving temporary additional value to a
brand, product or service to achieve scientific marketing objectives.
This includes distribution of free/sample pharmaceutical products.
Promotion must be ethical, accurate, balanced and must not be
misleading. Information in promotional materials must support proper
assessment of the risks and benefits of the product and its appropriate
use [Guiding Principle].
All promotional and educational material (including graphics and other
visual representations) must conform to generally accepted standards
of good taste and recognize the professional standing of the
recipients. These materials must not contain anything that would likely
cause serious or widespread offense against prevailing community
standards. [2.4]
Unqualified superlatives must not be used. All claims must not imply
that a product or an active ingredient is unique or has some special
merit, quality or property, unless the claim (s) can be substantiated.
The word safe for example must not be used without qualification.
[2.5]
Comparison of products must not be disparaging but must be factual,
fair and capable of substantiation and referenced to its source. Care
must be taken to ensure that it does not mislead by distortion, by
undue emphasis or by any other way. Clinical terminology, rather than
mere claims that a product is better, stronger or more widely
prescribed, should be used to describe improved benefits. [2.7.1]
Promotional information should not imitate the devices, copy, slogans,
or general layout adapted by other manufacturers in a way that is
101

How?

information/label?


likely to mislead or confuse [2.8]

Pharmaceutical Product 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 a healthcare professional, and which is intended for use
in the prevention, diagnosis and treatment of disease in humans, or to
affect the structure of any function of the human body [1.1]
The Code does not seek to regulate the following activities: promotion
/ advertising / detailing of over-the-counter products to the trade and
public.
It is the responsibility of companies, their employees and their medical
/ technical advisers to ensure that the contents of all promotional and
medical claims are balanced, accurate, correct and fully supported by
the Product Information, literature or Data on File or appropriate
industry source, where these do not conflict with the Product
Information. [2.1]
Products that have not been approved for registration by the FDA
cannot be promoted. This restriction also applies to unapproved
indications for registered products. [2.3.1]
Lay media advertising shall not be allowed for prescription products.
[4.8]
More specifications are given. It should encourage health seeking
behavior to appropriate healthcare professional. [16.1-16.10]
Advertisement in healthcare professional journals must contain the
following (a) brand name, (b) generic name of the active substances,
(c) name and address of the supplier, (d) full disclosure product
information in advertisements appearing within 12 months after
product launch, (e) the clause Please review product information
before prescribing and (f) date of production of the advertisement.
The minimum information needed when there is no promotional claims
: (g) brand name, (h) generic name, (i) name and address of the
supplier, (j) the statement Additional information is available upon
request [4.1]
102
MIMS advertising shall also abide by the requirement for journal

advertising [4.2]
Company commissioned articles must be identified and the PHAP
member responsible should be clearly identified at either the top of the
bottom of the article. It must conform to all relevant provisions. [4.3]

by media type.
Short advertisements in reference manuals shall correspond to the

requirements of full product information. [4.4]
All information, claims and graphical representations provided to
healthcare professionals and members of the general public must be
current, accurate, balanced and must not be misleading either directly
by implications or by omission. [2.3]
A full disclosure Product Information must accompany all promotional
materials for at least 12 months from the date of product launch.
Product Information should include (a) the brand name and the
generic name of each active substance, (b) pharmacological data, (c)
clinical information, (d) pharmaceutical information. [3.1]

Abridged disclosure product information (a) brand name, (b) approved

indications for use, (c) contraindications, (d) precautions, (e) adverse
effects and drug interactions, (f) available dosage forms and dosage
regimens, (g) routes of administration and (h) reference to special
groups of patients [3.2]
They should posses sufficient medical and technical knowledge to
present information on the companys products in an accurate,
current, and balanced manner, and should be cognizant of all
provisions of this Code. Members have a responsibility to maintain
high standards of continuing competency training for representatives
and shall be required to conduct the mandatory courses under the
Integrity and Proficiency Program in the Pharmaceutical Sector. They
103
should at all times, maintain a high standard of ethical conduct in

discharging their duties. They must conform to institutional regulations
governing their calls. They must provide the approved Product
Information whenever they make promotional claim. [8.1-8.5]
Promotional giveaway items, such as pens, notepads, t-shirts and

mugs, where no promotional claims are made do not require Product
Information. However these items should be of nature of economic
value (i.e., valued less than P1,000) which would bring discredit upon
the industry or the recipient. Items of higher cost may be donated to
institutions (such as medical societies, professional organizations, and
hospital departments) but never to individuals. [4.5.4]
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. [6.1]
Competitions must be based on medical knowledge or on the
acquisition of it. The process must be relevant and specific to the
practice of medicine. Prizes may include stethoscope and other
medical equipment. Individual prices offered are to be of low monetary
value or be items of educational material. Entry into a competition
must not depend on prescribing, ordering or recommending a product
and no such condition shall be made or implied. [6.2-6.5]

Guidelines on gifts specified [13.2]

Pharmaceutical companies interactions with stakeholders must at all
times be ethical, appropriate and professional. Nothing should be
offered or provided by a company in a manner or on conditions that
would have an inappropriate influence to ensure the independence of
the healthcare professional [Guiding Principle].
Pharmaceutical companies are responsible for providing accurate,
balanced, and scientifically valid data on products [Guiding Principle].
104
..provision of relevant information to healthcare providers. Such

information should include knowledge gained from the research and
development of medicines as well as from their clinical use.
Healthcare providers in the Philippines should have access to similar
data as those being communicated in developed countries [3.0]
Materials used by Medical Representatives: (a) claims must be
accompanied by product information; (b) printed and audiovisual
materials must contain full or abridged product information [4.5]
Limits of hospitality are described [11.7]
Hospitality and meal limitations specified [13.3]

No financial benefit or benefit-in-kind may be provided or offered to a
healthcare professional in exchange for prescribing or recommending
the product [17.0]
Discounts or coupons must not be given to patients directly but must
be through a qualified oversight of a physician and backed by
prescription. It should not be advertised and should not be tied to
sales promotion, raffles or promise of reward that may encourage self
medication.
In accordance with BFAD regulation, free samples of a
pharmaceutical product may be supplied to healthcare professionals
and only with their consent. Samples shold not be sold or otherwise
misused. The quantity should be enough to initiate therapy, gain
clinical experience. It may be given for humanitarian reasons with
healthcare provider supervision during dispensing. Product inserts
must accompany samples. Samples must comply with the labeling
requirements of BFAD. [9.1-9.5]
No company may organize or sponsor an event for healthcare
professionals that takes place outside of their home country unless it
is appropriate and justified to do so from the logistical or security point
of view. If travel is justified, travel should be by economy class. The
scientific agenda must be the primary basis for the companys
sponsorship of or participation in the event and any support to
105
individual doctors should not be conditional upon any obligation to

prescribe or promote any medicinal product [11.1-11.2]

Specific guidelines in company- or medical society-sponsored events

[11.9 and 12.0]
For pharmaceutical product related websites, the following guidelines
should be observed: (a) the identity of the pharmaceutical company
and of the intended audience should be readily apparent; (b) The
presentation [content, links, etc] should be appropriate and clear to the
intended audience; (c) country-specific information should comply with
local laws and regulations. [4.6.1]
Unsolicited electronic transmissions or replicas thereof must not be
used for promotional purposes [5.5]
Local websites have to follow all rules of the Code on promotion and
advertising. [7.0]
Whereas Post Marketing Surveillance ceases to be an FDA
requirement for drug registration, a member company is not banned
from conducting such activity in conformity with its risk management
strategies. However, healthcare providers are not to be compensated
for participation to such activities [14.7]
All clinical trials and scientific research sponsored or supported by
companies will be conducted with the intent to develop knowledge that
will benefit patients and advance science and medicine.
Pharmaceutical companies are committed to the transparency of
industry sponsored clinical trials in patients [Guiding Principles].
Detailed guidance on conduct of clinical studies and related activities
is described [14.0]
Products that have not been approved for registration by the FDA
cannot be promoted. This restriction also applies to unapproved
106
indications for registered products. [2.3.1]

All previously discussed rules apply to electronic promo materials,
including audiovisuals such as powerpoint presentations, CDs and
DVDs. [4.6.1]
24. Other
Mail, faxes, email and text messages must comply with all relevant
provisions of the Code and should be sent only to those categories of
healthcare professionals whose need for, or interest in, the particular
information can be reasonably assumed. Exposed mail, including
postcards, envelopes, and wrappers, must not carry matter that might
be regarded as advertising to the general public or that could be
considered unsuitable for public view. [5.0]
Exhibit booths must be directed only to healthcare professionals.
[10.2]
Details on arrangements for honoraria is described [14.8]
Companies may work with patient organizations but not for purposes
of promotion [15.0-15.5]

Code of Ethics of the Philippine Medical Association
advertisement?
How?
information/label?
107

by media type.
Only gifts of reasonable value that primarily entail benefit to patient

care or related to physicians work may be accepted by a physician
from a health product company [Article VI Section 3]
The physician shall not derive any form of material gain from product
samples [Article VI Section 1]
Continuing medical education conferences and professional meetings
must contribute to improve and optimize patients care or address the
educational needs of the targeted medical audience. They must be
organized by a medical society on its own or in cooperation with
sponsoring entities. [Article IV, Section 10]
Physicians may accept reasonable subsidies from health and other
industries to support their participation in CME events. [Article IV,
Section 12]
The faculty/speaker/consultant of conferences or meetings is allowed
to accept from health industries honoraria and reimbursement for
reasonable transportation, lodging and meals expenses [Section 13]
Scholarships for physicians and medical students are permissible as
long as the selection of scholars are made by the organizers or
academic institutions concerned. [Article IV, Section 14]
108
Generic names shall be used during the course of CME activities.

However, after the lectures, the sponsoring entity may promote or
indicate their branded products [Article IV, Section 15]

When commercial exhibits are part of the overall program,

arrangements for these should not influence the planning nor interfere
with the CME activities. Only relevant information of the product
should be included in the exhibit area. [Article IV, Section 16]
Written articles and scientific presentations in scientific conferences
should include full disclosure of any pharmaceutical support and
should be independent of any commercial influence [Article IV,
Section 7]
Physicians may participate in post-marketing or similar activities
where they are asked to try new products on patients provided that the
patients are properly informed and have given their informed consent.
Physicians are encouraged to report or share the result of such
activities to the duly constituted authorities [Article VI Section 2]
Research activities shall be ethically defensible, socially responsible
and scientifically valid. Any renumeration should be reasonable and
should not constitute an enticement. [Article VI Section 5]
Research trials conducted by physician for an industry should be done
in accordance with the national or institutional guidelines for the
protection of human subjects [Article VI Section 6]

24. Other
Funds from commercial sources may be accepted for the benefit of

the association or society [Article IV, Section 11]
Physicians may request donations for a charitable purpose for as long
as it does not redound to his or her personal benefit. [Article VI
Seciton 4]
109

ADBOARD Standards of Trade Practices and Conduct in the Advertising Industry, 4th Revision (2006)
Advertising any paid form of non-personal presentation and selling
of ideas, goods, or services by an Advertiser. Advertising may be
interchangeably used with advertisement, in any form of media or any
other communication devise designed for public exposure. [Section
IV.5]
Promotions refer to the practice of giving temporary additional value to
a product or service toward the realization of specific marketing
objectives [Section IV. 43]
In general advertising: must be self-regulating according to industry
advertisement?
standard of ethics
How?
information/label?
by media type.
110
24. Other
Issuing regulation/codes/guidelines
1. Which body (ies) issue (s) regulations on medicines promotion?
To carry out the provisions of this Act, there is hereby created an

office to be call the Bureau of Food and Drug in the Department of
Health. (RA 3720,Section 4)
The Bureau of Food and Drugs is hereby renamed the Food and Drug
Administration. (RA9711 Sec 1)
BFAD Legal Division in charge of all legal and certain aspects of
compliance and information activities of the bureau, including
monitoring of advertisements and promotions of products under BFAD
jurisdiction [RA 3720 Section 5f]
FDA Center for Drug Regulation and Research shall regulate the
manufacture, importation, exportation, distribution, sale, offer for sale,
transfer, promotion, advertisement, sponsorship of and/or where
appropriate the use and testing of health products [RA 9711 Section
5.a. 1]
111
2. What is its stated mission?
3. How is the body covered?
4. Number of full-time equipment staff for medicines promotion

regulation?
5. Budget for medicines promotion regulation in USD and as
percentage of total budget for pharmaceuticals
6. What are its other activities?
The guidelines for applications and approval of promotional,

advertisement, and/or sponsorship materials for pharmaceutical and
biological products, among other health products shall be formulated
and issued by the Center for Drug Regulation and Research (CDRR)
[FDA Circular 2013-024 Guideline 2]
Vision of FDA: Food and Drug Administration to be an internationally
recognized center of regulatory excellence safeguarding the health of
the Filipinos.
Mission of FDA: To ensure safety, efficacy, purity, and quality of
products we regulate through effective implementation of the national
regulatory framework consistent with international best practices.
[www.fda.gov.ph/about-food-and-drug-administration]
Said Bureau shall be under the Office of the Secretary and shall have
the following functions, powers and duties (RA 3720, Chapter III,
Section 4)
office to be called the Food and Drug Administration (FDA) in the
Department of Health (DOH). Said Administration shall be under the
Office of the Secretary. [RA 9711 Section 4]
Center Director (Center for Drug Regulation and Research); Division
Chief (Product Research and Standards Development Division)
RA9711 Sec5b2);
The appropriations for the BFAD and the BHDT included in the budget
of the DOH under the current General Appropriations Acts shall be
used to carry out the implementation of this Act (RA 9711 Sec 21)
FDAs functions, powers and duties:
Collection of samples, subsequent analysis, standard setting, issues
certificate of compliance, levy / assess / collect fees; covering, apart
from drugs food, cosmetics, and hazardous household products [RA
3720 Section 4]
Drug, Food, Cosmetics, and Devise (RA9711 Sec 5.1-4)
Activities: Regulation and Research;
BFAD is also the one of the responsible agency to implement the
112
7. Funding mechanisms (fees, fines and / or public funds?)
national drug policy (AO 48 s1988)

To levy, assess and collect fees for inspection, analysis and testing of
products and materials submitted in compliance with the provisions of
this Act (RA 3720, Chapter III, Section 4, f)
Fees and other income; can accept grants, donations and all other
endowments (RA9711 Sec 11)
The amount of one million pesos is hereby appropriated from any
funds in the national Treasury not otherwise appropriated to augment
the funds transferred to this Office under Section eight for the
implementation of this Act. All income derived from fees authorized in
Section four of this Act shall accrue to the General Fund. [RA 3720,
Section 32, amended]
8. How is information about regulation disseminated/made public?

Through official publications, newsletters, websites?
9. Can staff of the regulatory body also work in/be funded by the
pharmaceutical industry? Sit on boards?
10. To whom is the body responsible for issuing regulations

accountable?
For Director General and Deputy Director-General: A person who was

previously employed in a regular full-time capacity regardless of its
consultative designation at higher management supervisory levels in
regulated establishments, including related foundations, shall be
disqualified from appointment as director-general and deputy directorgeneral within three (3) years from termination of
employmentdirector-general and deputy director-general must
disclose all their incomes for the past three (3) years from all
establishments regulated by this Actdeclare any conflict of interest
(RA9711 Sec 7.g)
National drug committee will review from a technical standpoint all
decision and regulations of the BFAD, particularly those related to the
approval, disapproval, withdrawal, or restriction of drug products, prior
to final action by the Secretary of Health (AO 48 s1988)
Advisory Committee Board advises advise the Director of BFAD on
the following matters: recommend proposals to improve the technical
basis of regulatory implementation, streamline systems and
113
procedures, strengthen actual field effectivity of regulatory standards

and policies and enhance transparency and objectivity of regulatory
implementation (AO 48 s1988)
FDA should be under the Office of the Secretary (RA9711 Sec5)
A Congressional Oversight Committee is createdto oversee the
implementation of this Act for a period of five years and to review the
accomplishments and the utilization of income of the FDA (RA 9711
Sec 23)
Monitoring medicines promotion

1. Is there a governmental system is place for monitoring of medicines
promotion? Any other monitoring system, such as an industry selfregulatory system or other body?
Government
BFAD shall monitor advertisement and promotion of drug products as
well as receive complaints regarding these. On the basis of its
monitored finding or complaints, BFAD shall determine if any
advertising or promotional material violates these guidelines. [DOH
AO No 65 s1989, Section 4.4]
Industry Self-Regulation
The drug establishment under whose name the drug product is
registered shall be responsible for ensuring that its advertisement and
other promotional materials comply with these guidelines. It shall
establish suitable mechanism for internally reviewing such materials,
specifically with the participation of its medical directors. [DOH AO No
65 s1989, Section 4.1]
In addition, the drug establishment may participate in other industrywide mechanism for self-or voluntary regulation. Such participation,
however, shall not in anyway diminish the fundamental responsibility
and accountability of the drug establishment with respect to
compliance with these regulations. [DOH AO No 65 s1989, Section
4.2]
114
The PHAP Code of Practice covers not only member companies but
also local subsidiaries of IFPMA member companies [PHAP Guiding
Principles]
The General Manager / President / Managing Director is responsible
for the proper implementation of the Code and its implementing
Guidelines [PHAP 1.3]
The administration of PHAP 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 advise
externally. [PHAP 18.1]
2. If so, is it active monitoring (collection of samples, watching

television advertisements, pre-approval) or passive monitoring
(complaint mechanisms by competing companies and/or consumers)?
Describe
It is the responsibility of Companies to ensure that internal compliance

procedures exist that facilitate compliance with these Principles and
the spirit they embody. These procedures should be documented and
provided to employees to further enhance compliance. [Mexico City
Declaration Section 11]
The Commissioner of Customs shall cause to be delivered to the
Bureau samples taken at random from every incoming shipment of
food, drugs, devices, and cosmetics which are being imported or
offered for import into the Philippines giving notice thereof to the
owner or consigneeif with violationthe Director shall so inform the
Commissioner and such article shall be refused admission. Ifat a
post of entry other than Manila, the collection of such samples shall be
the responsibility of the Regional Food and Drug Supervisor having
jurisdiction over the port of entity and such samples shall be forwarded
to the Buresu. [Executive Order No 175 Section 23 Amending RA
115
3. Which body is responsible for monitoring?
3720 Section 30]

5.a. 1]
The CDRR shall implement compliance with the Mexico City
Principles and among others, monitor advertisements and other
marketing instruments and promotion, sponsorship, and other
marketing activities in the country. [FDA Circular No 2013-024
Guideline 3]
All monitoring, surveillance, and investigations on complaints and

violations pertinent to the provisions of Section 4.0 of the FDA Act of
2009 and other pertinent rules and regulations shall be conducted with
the assistance of the Regional Field Operation (RFO) Unit [FDA
Circular No 2013-024 Guideline 4]
the Filipinos.
116

5. How is the body governed?
6. Number of full-time equivalent staff for monitoring medicines
promotion?
7. Budget for monitoring medicines promotion in USD and as
8. What are the bodys other activities?
3720 Section 4]
9. Funding mechanisms (fees, fines and or/government?)
10. If pre-approval: Which material, on which media, for which

audience, for which substances?

No prior clearance from BFAD is required for initial printing and
broadcast or dissemination of advertisement and other promotional
materials for drug products. [DOH AO No 65 s1989, Section 4.3]
At least thirty (30) days before the actual commencement of the sales
promotion, applicant will file an application for sales promotion permit.
This will be processed within ten (10) working days upon receipt.
Seven (7) days before the actual activity, company can submit the
Notice or Invitation for Promo Supervision/Attestation of an Authorized
DOH-FDA representative. The request will be processed by Center for
Drug Regulation and Research [FDA MC 2013-028)
11. What are the criteria/requirements for pre-approval? Are they
117
publicly available? If so where?

12. Who develops those criteria?
13. Is there a fee for submitting promotional material for pre-approval?
How much is it in USD?
14. Is there is complaint mechanism, who can complain?

RA7394 Chapter III on Consumer Complaints [Articles 159-165]
FDA Public Assistance, Information, and Complaints Desk (eReport)
Contact [email protected]
With online portal
[www.fda.gov.ph/ereport]
Industry/Voluntary:
Member companies are encouraged to settle matters among
themselves before elevating the issue to the PHAP Ethics Committee.
Complainant could be from the industry or a private person. [19.2]
15. Are complaints published? Are the outcomes published?
16. What is the timeline for the complaint mechanism to be completed

from the time to complaint is filed?
Industry/Self-regulation:
A summary of the cases will be published on the PHAP website.
[PHAP 19.10]
RA7394 In hearing the complaint, the mediation officer shall use every
and all reasonable means to ascertain the facts in each complaints
speedily and objectively in suits before courts. The complaint shall be
decided within fifteen (15) days from the time the investigation was
terminated. [Art 163]
Industry/ Voluntary:
Complaints will be validated within five working days. If information
about the complaint is inadequate, the complainant must provide
additional information within the five working days. Within five working
118
days from receipt of a valid complaint, notice will be sent to the

respondent company. Response must be given within 15 working
days. Cases should be decided within 30 days from receipt of
respondents reply. An appeal can be made within 15 days to the
receipt of decision. The decision of the Appeals Board, given within 30
days is final and executory. [Section 19]
17. How is information about monitoring activities disseminated/made
public?
18. Can staff of the monitoring body also work in/be funded by the
pharmaceutical industry? Sit on industry boards?
19. To whom is the body responsible for monitoring accountable?

Sec 23)
Enforcing medicines promotion regulation

1. Which body enforces the law?

5.a. 1]
119
3. How is the body governed?

4. Number of full-time equivalent staff for enforcement of medicine
promotion regulation?
5. Budget for enforcing medicines promotion regulation in USD and as
6. What are its other activities?
All sanctions and penalties in violation of this Circular shall be

imposed by the CDRR in consultation with the Office of the FDA
Director General [FDA Circular No 2013-024 Guideline 5]
the Filipinos.
3720 Section 4]
7. Funding mechanisms (fees, fines and/or public funds?)

8. What are the sanctions: warning letters, issue of corrective
advertisement, prohibition of the advertisement, fines, revocation of
registration, jail, expulsion from association (for industry selfregulation?

Any advertising or promotional material found to be violative of these
guidelines will be identified and the drug establishment responsible
shall be notified. BFAD shall issue a cease and desist order stopping
the further release, printing, broadcast or dissemination of the violative
advertising or promotional material. [DOH AO No 65 s1989, Section
120
4.5]
On violations related to Generics Act:
RA 6675 Section 12
A. Any person who shall violate Section 6(a) or 6(b) of this Act shall
suffer the penalty graduated hereunder, viz:
1. For the first conviction, he shall suffer the penalty of
reprimand, which shall be officially recorded in the
appropriate books of the Professional Regulation
Commission;
2. The second conviction, the penalty of fine in the amount of
not less than two thousand pesos (P2,000).
3. For the third conviction, the penalty of fine in the amount of
not less than five thousand pesos (P5,000) but not exceeding
ten thousand pesos (P10,000) and suspension of his license
to practice his profession for thirty days at the discretion of
the court.
4. For the fourth subsequent convictions, the penalty of fine in
the amount of not less than ten thousand pesos (P10,000)
and suspension of his license to practice his profession one
year or longer at the discretion of the court.
B. Any judicial person violates Section , 6(d), 7 or 8 shall suffer the
penalty of fine of not less than five thousand pesos (P5,000) nor
more than ten thousand pesos (P10,000) and suspension or
revocation of license to operate such drug establishment or drug
outlet at the discretion of the Court: Provide, that its officers
directly responsible for the violation shall suffer the penalty of fine
and suspension or revocation of license to practice profession, if
applicable, and by imprisonment of not less than six (6) months
nor more than one (1) year of both fine and imprisonment at the
discretion of the Court: and provided further that if the guilty party
is an alien, he shall be ipso facto deported after service of
sentence without need of further proceedings.
C. The Secretary of Health shall have the authority to impose
administrative sanctions such as suspension or cancellation of
121
license to practice profession to the Professional Regulation

Commission as the case may be for the violation of the Act.
Sales promotion that involves misbranding [RA 3720 Section 12]
(a) Any person who violates any of the provisions of Section eleven
hereof shall, upon conviction, be subject to imprisonment of not
less than six months and one day, but not more than five years,
or a find of not less than one thousand pesos, or both such
imprisonment and fine, in the discretion of the Court.
Amended in [RA 9711 Section 11]
Any person who violates any of the provisions of Section eleven
hereof shall, upon conviction, suffer the penalty of imprisonment
ranging from one (1) year but not more than ten (10) years or a fine of
not less than fifty thousand pesos (P50,000) but not more than five
hundred thousand pesos (P500,000) or both at the discretion of the
court; There are also Administrative Sanctions
9. What is the range of sanctions (for fines: in USD). List offences and
sanctions range.
Industry / Self-Regulation
First offense is P 200,000
Succeeding offense of the same nature P 750,000 per offense
Clean slate if no violence of the same offense are committed within a
12-month period.
[PHAP 19.9]
If the drug establishment wishes to context BFADs findings, a formal
hearing shall be conducted. From finding after the hearing, BFAD shall
decide along the following possibilities: (a) the initial finding was found
untenable and the cease and desist order is then lifted, (b) the initial
finding was found valid so the cease and desist order remains [DOH
Repeated or serious violations of these guidelines may be regarded
by BFAD as indicative of the subject drug establishments inability to
perform adequately in a manner that assures the proper use of its
drug product. Under such condition and after due hearing, BFAD may
impose the following sanctions: withdrawal by BFAD of the
122
accreditation of the establishments medical director; suspension of

the license to operate of the drug establishment; cancellation of the
certification of product registration; and revocation of the license to
operate of the drug establishment. [DOH AO No 65 s1989, Section
4.7]
On violations related to Generics Act:
RA 6675 Section 12
D. Any person who shall violate Section 6(a) or 6(b) of this Act shall
suffer the penalty graduated hereunder, viz:
5. For the first conviction, he shall suffer the penalty of
reprimand, which shall be officially recorded in the
appropriate books of the Professional Regulation
Commission;
6. The second conviction, the penalty of fine in the amount of
not less than two thousand pesos (P2,000).
7. For the third conviction, the penalty of fine in the amount of
not less than five thousand pesos (P5,000) but not exceeding
ten thousand pesos (P10,000) and suspension of his license
to practice his profession for thirty days at the discretion of
the court.
8. For the fourth subsequent convictions, the penalty of fine in
the amount of not less than ten thousand pesos (P10,000)
and suspension of his license to practice his profession one
year or longer at the discretion of the court.
E. Any judicial person violates Section , 6(d), 7 or 8 shall suffer the
penalty of fine of not less than five thousand pesos (P5,000) nor
more than ten thousand pesos (P10,000) and suspension or
revocation of license to operate such drug establishment or drug
outlet at the discretion of the Court: Provide, that its officers
directly responsible for the violation shall suffer the penalty of fine
and suspension or revocation of license to practice profession, if
applicable, and by imprisonment of not less than six (6) months
nor more than one (1) year of both fine and imprisonment at the
discretion of the Court: and provided further that if the guilty party
123
10. Are the sanctions made public? How?
11. Is there an appeal mechanism?
12. Who can appeal? To whom?

13. What is the timeline for the appeal process from when the appeal
is launched until its completion?
14. Can staff of the enforcement body also work in/be funded by the
pharmaceutical industry? Sit on industry boards?
15. To whom is the body responsible for enforcement accountable?
is an alien, he shall be ipso facto deported after service of

sentence without need of further proceedings.
F. The Secretary of Health shall have the authority to impose
administrative sanctions such as suspension or cancellation of
license to practice profession to the Professional Regulation
Commission as the case may be for the violation of the Act.
Nothing in this Section shall be construed to prohibit the Secretary
from collecting, reporting, and illustrating the results of the
investigations of the Department. [Executive Order 175 Section 21,
Amending RA 3720 Section 29]
If the drug establishment wishes to context BFADs findings, a formal
hearing shall be conducted. From finding after the hearing, BFAD shall
decide along the following possibilities: (a) the initial finding was found
untenable and the cease and desist order is then lifted, (b) the initial
finding was found valid so the cease and desist order remains [DOH
All pleadingsshall be filed with the docketing unit in the FDA Central
Office..[DOH DC 2011-0101 Article V Section 1]
Within five (5) days from the commencement of action, summons shall
be served on the respondent/s, attaching thereto the
complaint/petitionanswer within a non-extensible period of ten (10)
days from receipt of the summonspreliminary conference not later
than fifteen (15) days from the receipt of the answerin cases where
a preliminary conference / clarificatory hearing is conducted, within
fifteen (15) days from the termination thereof, the parties shall
simultaneously submit their respective position paperwithin fifteen
(15) days from the time the case is submitted for decision, the regional
field director shall make his/her findings and recommendations in
wirting15 days with the deputy director general15 days with the
director general..final and executor within 15 days, may file a motion
for reconsideration within this 15 days
124

Sec 23)
16. Are civil society and/or other stakeholders asked for comments on
pending decisions?
17. Are the reasons for the decisions published?
Others
1. What are the relationships between the different
bodies/departments involved in medicines promotion regulation
(issuing regulations, monitoring and enforcement)
2. Do companies producing and/or selling medicines have to disclose

their budget for promotion and advertising? How and where is this
disclosure made? How much is that budget at a national level for a
given year?
3. How is generic substitution regulated? (e.g., substitution by
pharmacists)
4. How is prescribing regulated?
RA 7394 Title V The National Consumers Affairs Council

To improve the management, coordination and effectiveness of
consumer programshall be composed of representatives from the
following government agencies and non-government agenciesDOH
[Art 148, 149]
Generic Dispensing means dispensing the patients/buyers choice

from among generic equivalent i.e., finished pharmaceutical products
having the same active ingredients, same dosage form and same
strength as the prescribed drug [DOH AO 62 s1989 1.4]
All drug outlets are required to practice generic dispensing with some
exemptions, modifications or qualifications[DOH AO 63 s1989 3.1]
* Informed choice of patient/buyer [3.1.1]
All medical, dental and veterinary practitioners, including private
practitioners, shall write prescriptions using generic name. The brand
name maybe included if so desired. [RA 6675 Section 6.a.]
DOH AO 62 s1989
1.1 Only validly-registered medical, dental and veterinary
practitionersare authorized to prescribe drugs.
1.2 all prescriptions must contain the following information: name
125
5. Is there a legal provision requiring the government to provide

independent information on medicines to health professionals and/or
consumers?
of prescriber, office address, professional registration number,

professional tax receipt number, patients/clients name, age, sex,
and date of prescription
1.3 (Specific restriction for dangerous drugs)
Section 3 use of generics in prescription
The Department of Health shall publish annually in at least two
newspapers of general circulation in the Philippines the generic
names, and the corresponding brand name under which they are
marketed, of all drugs and medicines available in the Philippines. [RA
6675 Section 5]
The Department of Health jointly with the Department of Education,
Culture and Sports, Philippine Information Agency and the
Department of Local Government shall conduct a continuous
information campaign for the public and a continuing education and
training for the medical and allied medical profession on drugs with
generic names as an alternative of equal efficacy to the more
expensive brand name drug. [RA 6675 Section 11]
The Secretary may cause to be disseminated information regarding
foods, drugs, devices or cosmetics in situations involving in the
opinion of the Secretary, imminent danger to health, or gross
deception to the consumer. [Executive Order 175 Section 21,
Amending RA 3720 Section 29]
DOH is also one of the key government agencies mandated to
promote use of generic terminology through public information and
continuing education of health professionals; [DOH AO 51 s1988, 5.3]
126

Medicines Promotion - Assessing The Nature, Extent and Impact of Regulation in The Philippines

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Pilot of the HAI / MeTA Tool

4.0 RESULTS .................................................................................................................................................. 4

ANNEX A1. INTERVIEW SCHEDULE: KEY INFORMANT FROM DRUG REGULATORY

Medicines are important in the management of diseases. Its beneficial use is

strengthen ethical practice by pharmaceutical companies with respect to their

The general objective of this study is to develop country-specific policy

Provide a detailed overview of the current regulatory structure for medicines

Assess the effectiveness of pharmaceutical promotions regulations and

Identify gaps in the medicines regulatory framework which need to be

Assess the effectiveness of the HAI/MeTA methodology as a tool to

The scope of Philippines regulatory framework on medicinal drug promotion was

systematically catalogued using the Document Checklist, a tool developed by

Four respondents representing different roles and functions in

schedule during the interview phase

Majority of the interviews were conducted in a face-to-face meeting in a venue most

4.1. Nature and Scope of Regulation

WHO Ethical Criteria for Medicinal Drug Promotion (1988)5

The World Health Assembly brought forth a recommended framework

Mexico City Principles for Voluntary Codes of Business Ethics in the

Six principles were set to guide relationships of pharmaceutical companies

International Federation of Pharmaceutical Manufacturers & Associations

WHO (1988). Ethical criteria for medicinal drug promotion

WHO Ethical Criteria for

The Mexico City

Guiding Principle, 2.4,

DOH AO 65 1989 s1.1

Consumer Act of the

Section 2.A, Section

Consumer Act of the

DOH AO 65 1989 s3.1

DOH AO 65 1989 s2.1

FDA Act 2009 Section

4.8, 16.1 to 16.10

4.1, 4.2, 4.4

2.3, 3.1, 3.2

Generics Act of 1988,

DOH AO 65 1989 s2.3

Generics Act of 1988,

Similar requirements for

DOH A0 65 1989 s2.4

Philippine 1987 Constitution, Article II Section 15

FDA Circular No 2013-024 Objectives and Rationale

Executive Order Numbers 174 and 175 Section 3

Advertising compliance with approved product information level

DOH AO 65 s 1989 Section 3.1

DOH AO 65 Section 3.3

Requirement for Pharmaceutical Sales Representatives

APEC (2013) The Mexico City Principles Section 12.A.1

WHO Ethical Criteria for

The Mexico City

FDA Circular 2013-024,

Section 8.A.1, Section

Section 4, Section 4.c

Article VI, Section 10,

Article IV, Section 7

EO 175 1987 s7 and

Gifts and payments to

4.5.5, 6.1, 6.2 to 6.5,